Tissue ingrowth materials and method of using the same

ABSTRACT

Implantable materials for use with end effectors like surgical stapling devices, and methods for using the same, are generally provided. In some embodiments, adjunct materials for use with surgical staplers are provided. For example, a kit for stapling tissue is provided that can include a surgical stapler having an end effector. The end effector can have first and second jaws. The kit can include an adjunct material having hydrophobic surface regions and hydrophilic surface regions and the adjunct material can be configured to mate to at least one of the jaws of the end effector. Other implants, devices, and methods for surgical stapling are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/296,977 filed Mar. 8, 2019, entitled “Tissue Ingrowth Materials andMethod of Using the Same,” which is a continuation of U.S. patentapplication Ser. No. 15/645,293 (now U.S. Pat. No. 10,285,691), filedJul. 10, 2017, entitled “Tissue Ingrowth Materials and Method of Usingthe Same,” which is a continuation of U.S. patent application Ser. No.14/075,459 (now U.S. Pat. No. 9,700,311), filed Nov. 8, 2013, andentitled “Tissue Ingrowth Materials and Method of Using the Same,” whichare hereby incorporated by reference herein in their entireties.

FIELD

The present invention relates to surgical instruments, and in particularto methods, devices, and components thereof for cutting and staplingtissue.

BACKGROUND

Surgical staplers are used in surgical procedures to close openings intissue, blood vessels, ducts, shunts, or other objects or body partsinvolved in the particular procedure. The openings can be naturallyoccurring, such as passageways in blood vessels or an internal organlike the stomach, or they can be formed by the surgeon during a surgicalprocedure, such as by puncturing tissue or blood vessels to form abypass or an anastomosis, or by cutting tissue during a staplingprocedure.

Most staplers have a handle with an elongate shaft having a pair ofmovable opposed jaws formed on an end thereof for holding and formingstaples therebetween. The staples are typically contained in a staplecartridge, which can house multiple rows of staples and is oftendisposed in one of the two jaws for ejection of the staples to thesurgical site. In use, the jaws are positioned so that the object to bestapled is disposed between the jaws, and staples are ejected and formedwhen the jaws are closed and the device is actuated. Some staplersinclude a knife configured to travel between rows of staples in thestaple cartridge to longitudinally cut and/or open the stapled tissuebetween the stapled rows.

While surgical staplers have improved over the years, a number ofproblems still present themselves. One common problem is that leaks canoccur due to the staple forming holes when penetrating the tissue orother object in which it is disposed. Blood, air, gastrointestinalfluids, and other fluids can seep through the openings formed by thestaples, even after the staple is fully formed. The tissue being treatedcan also become inflamed due to the trauma that results from stapling.Still further, staples, as well as other objects and materials that canbe implanted in conjunction with procedures like stapling, generallylack some characteristics of the tissue in which they are implanted. Forexample, staples and other objects and materials can lack the naturalflexibility of the tissue in which they are implanted. A person skilledin the art will recognize that it is often desirable for tissue tomaintain as much of its natural characteristics as possible afterstaples are disposed therein.

In some instances, biologic materials have been used in conjunction withtissue stapling. However, the use of biologic materials can present anumber of problems. For example, biologics can lack desired mechanicalproperties such as the ability to seal around fastener components (e.g.,surgical staples) inserted therethrough. Biologics can also lack theability to sufficiently reinforce tissue at a surgical site and/oraddress bleeding or fluid at a surgical site.

Additionally, it can be difficult to maintain a location of the biologicmaterial with respect to jaws of the stapler prior to and during stapleejection. It can also be difficult to keep the biologic material at adesired location at the surgical site after stapling is completed.Further, it can be difficult to manufacture the biologic material to adesired shape and thickness. Common plastic and molding manufacturingtechniques are not generally conducive to the manufacture of thinbiologic layers for use in conjunction with surgical staplers. Thefragile nature of many biologic materials also makes them difficult touse with surgical staplers because they lack structural support.

Further, in some instances, biologic materials have been used inconjunction with tissue stapling. However, the use of biologic materialshas presented a number of problems. For example, biologics can lackdesired mechanical properties such as springiness or elasticity (i.e.,they do not recover, or spring back, after being compressed). Biologicscan lack the ability to sufficiently reinforce tissue at a surgicalsite. Further, it can sometimes be difficult or even impossible tomanufacture biologic materials to an exact required shape and/orthickness (e.g., to compensate for variations in tissue thickness, whichmight only be known at the time of surgery).

Accordingly, there remains a need for improved devices and methods forstapling tissue, blood vessels, ducts, shunts, or other objects or bodyparts such that leaking and inflammation is minimized whilesubstantially maintaining the natural characteristics of the treatmentregion. There further remains a need for improved implantable materialsthat include biologics.

SUMMARY

Implantable materials for use with end effectors like surgical staplingdevices, and methods for using the same, are generally provided. In someembodiments, adjunct materials for use with surgical staplers areprovided. For example, a kit for stapling tissue is provided that caninclude a surgical stapler having an end effector. The end effector canhave first and second jaws. The kit can include an adjunct materialhaving hydrophobic surface regions and hydrophilic surface regions andthe adjunct material can be configured to mate to at least one of thejaws of the end effector.

In some embodiments, the adjunct material can be formed from ahydrophobic polymer and/or coploymer that is treated with a hydrophilicpolymer. The adjunct material can also be formed from a hydrophobicpolymer and/or coploymer that is treated with an acid or base. In someembodiments, the adjunct material can be formed from a hydrophobicpolymer that is treated by covalently bonding hydrophilic moieties ontoat least a portion of the hydrophobic polymer. The hydrophilic surfaceregion can be laminated to the hydrophobic surface region. The adjunctmaterial can include an absorbable polymer. In some embodiments, theadjunct material can include a copolymer selected from the groupconsisting of polyglycolic acid/polycaprolactone and polylacticacid/polycaprolactone. Also, the adjunct material can include a foam.

In some exemplary embodiments a staple cartridge assembly for use with asurgical stapler, can include a cartridge body having a plurality ofstaples disposed therein and an adjunct material configured to becoupled to the cartridge and configured to be securely attached totissue by staples in the cartridge. The adjunct material can have ahydrophobic surface region and an opposite hydrophilic surface region.In some embodiments, the adjunct material can be formed from ahydrophobic polymer and/or coploymer that is treated with a hydrophilicpolymer. The adjunct material can also be formed from a hydrophobicpolymer and/or coploymer that is treated with an acid or base. In someembodiments, the adjunct material can be formed from a hydrophobicpolymer that is treated by covalently bonding hydrophilic moieties ontoat least a portion of the hydrophobic polymer. In some embodiments, thehydrophilic surface region can be configured to directly contact tissuewhen secured to tissue by the staples such that tissue ingrowth isencouraged. The adjunct material can include a copolymer selected fromthe group consisting of polyglycolic acid/polycaprolactone andpolylactic acid/polycaprolactone. In some embodiments, the adjunctmaterial include a polyglycolic acid/polycaprolactone copolymer havingpolyethylene glycol and/or poloxamer repeat units. The adjunct materialcan include at least one of a biologic material, an electrically chargedmaterial, and an internal support structure. Also, the adjunct materialcan include a foam.

In other aspects, a method for stapling tissue is provided. The methodcan include attaching an adjunct material to an end effector on asurgical stapling device such that a hydrophobic surface on the adjunctmaterial directly contacts the end effector. The method can also includeengaging tissue between the jaws of the end effector such that ahydrophilic surface on the adjunct material directly contacts thetissue, and actuating the end effector to eject at least one staple fromthe end effector into the tissue. The at least one staple can extendthrough the adjunct material to attach the adjunct material to thetissue. In some embodiments, the adjunct material can include apolyglycolic acid/polycaprolactone copolymer having polyethylene glycoland/or poloxamer repeat units. Also, the hydrophilic surface can includea first layer of material and the hydrophobic surface can be a coatingthat is laminated to the first layer of material.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a perspective view of one exemplary embodiment of a surgicalinstrument having an attachment portion attached to a distal endthereof;

FIG. 2 is a perspective view of the surgical instrument of FIG. 1 withthe attachment portion detached from a shaft of the instrument;

FIG. 3 is a perspective view of the attachment portion of FIG. 2including at least one piece of adjunct material;

FIG. 4 is an exploded perspective view of the end effector of FIG. 3with the adjunct material removed;

FIG. 5 is a detailed perspective view of a distal end of a staplecartridge for use with the end effector of FIG. 4;

FIG. 6 is a side cross-sectional view taken along the section lineindicated in FIG. 5;

FIG. 7 is a bottom perspective view of the staple cartridge of FIG. 5;

FIG. 8 is an exploded perspective view of an actuation sled, pushers,and fasteners of the surgical instrument of FIG. 4;

FIG. 9 is a perspective view of another exemplary embodiment of anattachment portion for use a surgical instrument;

FIG. 10 is an exploded perspective view of an end effector of theattachment portion of FIG. 9;

FIG. 11 is an exploded view of a drive assembly for use with the endeffector of FIG. 4;

FIG. 12 is a perspective view of a lower jaw of the end effector of FIG.3;

FIG. 13 is a perspective view of an upper jaw of the end effector ofFIG. 3, the upper jaw having an adjunct material associated therewith;

FIG. 14 is a perspective view of portions of the end effector of FIG. 2including a retention member configured to releasably retain an adjunctmaterial;

FIG. 15 is a perspective view of a lower jaw of the end effector of FIG.10;

FIG. 16 is a perspective view of portions of an end effector having anadjunct material associated therewith;

FIG. 17A is a partial cutaway view of an exemplary adjunct materialhaving a drop of water disposed thereon;

FIG. 17B is a partial cutaway view of an exemplary hydrophobic adjunctmaterial having a drop of water disposed thereon;

FIG. 17C is a cross-sectional view of an exemplary hydrophilic adjunctmaterial having a drop of water disposed thereon;

FIG. 18A is a side view of an adjunct material maintained adjacent atissue to be treated and an adjacent organ by staples;

FIG. 18B is a cross-sectional view of an exemplary adjunct materialdisposed between a tissue to be treated and an adjacent organ;

FIG. 19A is a perspective view of an exemplary adjunct material havingsurface features;

FIG. 19B is a perspective view of another exemplary adjunct materialhaving surface features;

FIG. 19C is a perspective view of yet another exemplary adjunct materialhaving surface features;

FIG. 20A is a scanning electron microscope image of an exemplary adjunctmaterial having surface features;

FIG. 20B is a scanning electron microscope image of another exemplaryadjunct material having surface features;

FIG. 20C is a scanning electron microscope image of yet anotherexemplary adjunct material having surface features;

FIG. 21A is a scanning electron microscope image of an exemplary adjunctmaterial having surface features;

FIG. 21B is a scanning electron image of another exemplary adjunctmaterial having surface features;

FIG. 21C is a scanning electron image of yet an exemplary adjunctmaterial having surface features;

FIG. 22A is a perspective view of an exemplary adjunct material havingsurface features;

FIG. 22B is a perspective view of another exemplary adjunct materialhaving surface features;

FIG. 22C is a perspective view of yet another exemplary adjunct materialhaving surface features;

FIG. 23 illustrates an end effector having a tissue reinforcementmaterial with a plurality of fibers in a loop structure arrangement;

FIG. 23A is a detail view of a portion of the tissue reinforcementmaterial of FIG. 23.

FIG. 23B is a schematic view of a portion of a strand of fiber used toform the tissue reinforcement material of FIG. 23;

FIG. 23C is a sectional view of the strand of fiber of FIG. 23B atsection AA;

FIGS. 24A and B illustrate exploded views of an exemplary tissuereinforcement material having a plurality of fibers in a loop structurearrangement shown compressing and sealing around a fastener component;

FIG. 25 illustrates another exemplary embodiment of a tissuereinforcement material having vertical and radial springiness;

FIG. 26 illustrates a perspective view of an end effector having analternative exemplary tissue reinforcement material with a collagenmatrix that can seal around a fastener component;

FIGS. 27 and 28 illustrate an exploded cross sectional views of anexemplary fastener inserted through tissue and the tissue reinforcementmaterial of FIG. 26;

FIG. 29 illustrates a portion of tissue having a stapled section and asection with an exemplary hybrid adjunct tissue reinforcement materialafter deployment in tissue;

FIG. 30A is an isometric view of an alternative exemplary tissuereinforcement material including a surgical adhesive that seals around afastener component;

FIG. 30B is a side view of the tissue reinforcement material of FIG. 30Abefore penetration by a surgical staple;

FIG. 30C is an isometric view of the tissue reinforcement material ofFIG. 30B after penetration by a surgical staple;

FIG. 31A is a sectional view of opposed jaws of an end effector havinganother alternative exemplary tissue reinforcement material;

FIG. 31B is a detailed view of portions of the tissue reinforcementmaterial on the jaws of the end effector of FIG. 31A;

FIG. 31C is a perspective view of two layers of the tissue reinforcementmaterial shown in FIGS. 31A and 31B;

FIGS. 32A-C illustrate an exemplary method for implanting a tissuereinforcement material;

FIG. 33A is a perspective view of a cell dispersion having unchargedpolymer spheres;

FIG. 33B is a perspective view of a cell dispersion having positivelycharged polymer spheres;

FIG. 34 is a schematic view of an embodiment of a mechanism ofelectrically charged implant material enhancing healing at a wound site;

FIG. 35A is a perspective exploded view of one exemplary embodiment of ahybrid adjunct material and a lower jaw of an end effector;

FIG. 35B is a front cross-sectional view of the hybrid adjunct materialof FIG. 35A in a non-exploded configuration and taken along line A-A,and further illustrating a second hybrid adjunct material coupled to anupper jaw of the end effector;

FIG. 36 is a perspective cross-sectional view of another exemplaryembodiment of a first hybrid adjunct material coupled to a lower jaw ofan end effector and a second hybrid adjunct material coupled to an upperjaw of the end effector;

FIG. 37 is a perspective view of yet another exemplary embodiment of ahybrid adjunct material coupled to a lower jaw of an end effector, witha portion of a biologic layer of the hybrid adjunct material removed forillustrative purposes;

FIG. 38 is a perspective view of one exemplary embodiment of a syntheticlayer of a hybrid adjunct material coupled to a lower jaw of an endeffector;

FIG. 39 is a perspective view of another exemplary embodiment of asynthetic layer of a hybrid adjunct material coupled to a lower jaw ofan end effector, and further including a biologic layer configured tocouple to the synthetic layer;

FIG. 40A is a perspective view of one exemplary embodiment of anattachment portion of a surgical instrument having a synthetic layercoupled to a lower jaw thereof;

FIG. 40B is a perspective view of the lower jaw of FIG. 40A and abiologic layer configured to couple to the synthetic layer;

FIG. 40C is a front cross-sectional view illustrating the biologic layerof FIG. 40B partially coupled to the synthetic layer;

FIG. 40D is a front cross-sectional view illustrating the biologic layerof FIG. 40B fully coupled to the synthetic layer.

FIG. 40E is a perspective view of the lower jaw of FIG. 40A with thebiologic layer fully coupled to the synthetic layer and a portion of thebiologic layer removed for illustrative purposes;

FIG. 41A is a perspective view of another exemplary embodiment of anattachment portion of a surgical instrument having a hybrid adjunctmaterial coupled to an upper jaw thereof;

FIG. 41B is a perspective view of the upper jaw of FIG. 41A;

FIG. 42A is a perspective view of one exemplary embodiment of an upperjaw of an end effector having a biologic material coupled thereto;

FIG. 42B is a detailed schematic view of a surgical site illustrating astaple disposed both in tissue and in the biologic material of FIG. 42A;

FIG. 42C is a detailed schematic view of the surgical site of FIG. 42Billustrating the staple after it is fully formed;

FIG. 43A is a perspective view of another exemplary embodiment of anupper jaw of an end effector having two biologic layers coupled thereto,with a portion of a first biologic layer removed for illustrativepurposes;

FIG. 43B is a detailed view of the two biologic layers of FIG. 43A;

FIG. 43C is a detailed schematic view of a surgical site illustrating astaple disposed both in tissue and through the two biologic layers ofFIG. 43B;

FIG. 43D is a detailed schematic view of the surgical site of FIG. 43Cillustrating the staple after it is fully formed;

FIG. 44A is a perspective view of one exemplary embodiment of a hybridadjunct material having a snap-fit configuration between a biologiclayer and a synthetic layer thereof;

FIG. 44B is a perspective view of another exemplary embodiment of ahybrid adjunct material having biologic layer laminated to a syntheticlayer;

FIG. 44C is a perspective view of still another exemplary embodiment ofa hybrid adjunct material having biologic materials imbibed in asynthetic layer;

FIG. 45A is a perspective view of one exemplary embodiment of packagingfor a surgical instrument having a synthetic layer of a hybrid adjunctmaterial associated therewith;

FIG. 45B is a perspective view of one exemplary embodiment of packagingfor a biologic layer, the biologic layer being configured to mate withthe synthetic layer of FIG. 45A;

FIG. 46 is a perspective view of an exemplary staple cartridge having ahybrid adjunct material in accordance with the present invention;

FIGS. 47-49 are perspective views illustrating exemplary attachments ofbiological tissue reinforcement membranes to cartridge bodies, andexemplary compressible elastic members;

FIG. 50A-50C is an exploded view of variations of the compressibleelastic members illustrated in FIGS. 47-49; and

FIGS. 51-53 are cross sectional views illustrating the operation of theexemplary staple cartridge of FIG. 46.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention. Further, in the present disclosure,like-numbered components of the various embodiments generally havesimilar features when those components are of a similar nature and/orserve a similar purpose.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment,” or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” or “in an embodiment,” or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation. Such modifications and variations are intended to beincluded within the scope of the present invention.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, aperson skilled in the art will appreciate that the various methods anddevices disclosed herein can be used in numerous surgical procedures andapplications. Those skilled in the art will further appreciate that thevarious instruments disclosed herein can be inserted into a body in anyway, such as through a natural orifice, through an incision or puncturehole formed in tissue, or through an access device, such as a trocarcannula. For example, the working portions or end effector portions ofthe instruments can be inserted directly into a patient's body or can beinserted through an access device that has a working channel throughwhich the end effector and elongated shaft of a surgical instrument canbe advanced.

It can be desirable to use one or more biologic materials and/orsynthetic materials, collectively referred to herein as “adjunctmaterials,” in conjunction with surgical instruments to help improvesurgical procedures. A person skilled in the art may refer to thesetypes of materials as buttress materials as well as adjunct materials.While a variety of different end effectors can benefit from the use ofadjunct materials, in some exemplary embodiments the end effector can bea surgical stapler. When used in conjunction with a surgical stapler,the adjunct material(s) can be disposed between and/or on jaws of thestapler, incorporated into a staple cartridge disposed in the jaws, orotherwise placed in proximity to the staples. When staples are deployed,the adjunct material(s) can remain at the treatment site with thestaples, in turn providing a number of benefits. In some instances, thematerial(s) can be used to help seal holes formed by staples as they areimplanted into tissue, blood vessels, and various other objects or bodyparts. Further, the materials can be used to provide tissuereinforcement at the treatment site. Still further, the materials canhelp reduce inflammation, promote cell growth, and otherwise improvehealing.

Some configurations of adjunct materials include both synthetic andbiologic materials. The combination of both types of materials canresult in the formation of a hybrid adjunct material. Hybrid adjunctmaterials, when properly designed and/or selected, can combinebeneficial features of synthetic material(s) and beneficial features ofbiologic material(s) in a single hybrid adjunct material. Thus, while anotherwise desirable biologic material may lack an also desirablemechanical (or other) property, combining the biologic material with asynthetic material providing that mechanical (or other) property canprovide a hybrid adjunct material having both desirable properties. Forexample, a hybrid adjunct material can be designed to combine benefitsof biologic material (such as improved healing and tissue growth at asurgical site) with desirable mechanical properties of syntheticmaterial (such as an ability to compress and form a seal around afastener component).

Further, while often biologic material can be difficult to shape into adesired shape and then held in that desired configuration, by usingsynthetic material in conjunction with the biologic material, thesynthetic material can serve as a support structure for the biologicmaterial. Accordingly, the benefits of biologic material, such asimproved healing and tissue growth at the surgical site, can be providedwith the stability afforded by synthetic material.

As another example, For example, a hybrid adjunct material can bedesigned to combine benefits of biologic material (such as improvedhealing and tissue growth at a surgical site) with desirable mechanicalproperties of synthetic material (such as springiness or elasticity inthe resulting hybrid adjunct material).

Surgical Stapling Instrument

While a variety of surgical instruments can be used in conjunction withthe adjunct materials disclosed herein, FIGS. 1 and 2 illustrate one,non-limiting exemplary embodiment of a surgical stapler 10 suitable foruse with one or more adjunct materials. As shown the instrument 10includes a handle assembly 12, a shaft 14 extending distally from adistal end 12 d of the handle assembly 12, and an attachment portion 16removably coupled to a distal end 14 d of the shaft 14. Because theillustrated embodiment is a surgical stapler, a distal end 16 d of theattachment portion 16 includes an end effector 50 having jaws 52, 54,although other types of end effectors can be used with the shaft 14,handle assembly 12, and components associated with the same. As shown,the surgical stapler includes opposed first and second jaws 52, 54 withthe first, lower jaw 52 including an elongate channel 56 (FIG. 4)configured to support a staple cartridge 100, and the second, upper jaw54 having an inner surface 58 (FIGS. 3, 4, and 6) that faces the lowerjaw 52 and that is configured to operate as an anvil to help deploystaples of a staple cartridge. The jaws 52, 54 are configured to moverelative to one another to clamp tissue or other objects disposedtherebetween, and an axial drive assembly 80 (FIG. 11) can be configuredto pass through at least a portion of the end effector 50 to eject thestaples into the clamped tissue. In various embodiments a knife blade 81can be associated with the axial drive assembly 80 to cut tissue duringthe stapling procedure.

Operation of the end effector 50 and drive assembly 80 can begin withinput from a clinician at the handle assembly 12. The handle assembly 12can have many different configurations designed to manipulate andoperate the end effector associated therewith. In the illustratedembodiment, the handle assembly 12 has a pistol-grip type housing 18with a variety of mechanical components disposed therein to operatevarious features of the instrument. For example, the handle assembly 12can include mechanical components as part of a firing system actuated bya trigger 20. The trigger 20 can be biased to an open position withrespect to a stationary handle 22, for instance by a torsion spring, andmovement of the trigger 20 toward the stationary handle 22 can actuatethe firing system to cause the axial drive assembly 80 to pass throughat least a portion of the end effector 50 and eject staples from astaple cartridge disposed therein. A person skilled in the art willrecognize various configurations of components for a firing system,mechanical or otherwise, that can be used to eject staples and/or cuttissue, and thus a detailed explanation of the same is unnecessary.

Other non-limiting examples of features that can be incorporated intothe handle assembly 22 that affect manipulation and operation of an endeffector associated therewith include a rotatable knob 24, anarticulation lever 26, and retraction knobs 28. As shown, the rotatableknob 24 can be mounted on a forward end of a barrel portion 30 of thehandle assembly 12 to facilitate rotation of the shaft 14 (or theattachment portion 16) with respect to the handle assembly 12 around alongitudinal axis L of the shaft 14. The actuation lever 26 can also bemounted on a forward end of the barrel portion 30, approximatelyadjacent to the rotatable knob 24. The lever 26 can be manipulated fromside-to-side along a surface of the barrel portion 30 to facilitatereciprocal articulation of the end effector 50. One or more retractionknobs 28 can be movably positioned along the barrel portion 30 to returnthe drive assembly 80 to a retracted position, for example after thefiring system has completed a firing stroke. As shown, the retractionknobs 28 move proximally toward a back end of the barrel portion 30 toretract components of the firing system, including the drive assembly80.

Still other non-limiting examples of features that can be incorporatedinto the handle assembly 22 that affect manipulation and operation of anend effector associated therewith can include a firing lockout assembly,an anti-reverse clutch mechanism, and an emergency return button. Afiring lockout assembly can be configured to prevent the firing systemfrom being actuated at an undesirable time, such as when an end effectoris not fully coupled to the instrument. An anti-reverse clutch mechanismcan be configured to prevent components of the firing system from movingbackwards when such backwards movement is undesirable, such as when thefiring stroke has only been partially completed but temporarily stopped.An emergency return button can be configured to permit components of afiring system to be retracted before a firing stroke is completed, forinstance in a case where completing the firing stroke may cause tissueto be undesirably cut. Although features such as a firing lockoutassembly, an anti-reverse clutch mechanism, and an emergency returnbutton are not explicitly illustrated in the instrument 10, a personskilled in the art will recognize a variety of configurations for eachfeature that can be incorporated into a handle assembly and/or otherportions of a surgical stapler without departing from the spirit of thepresent disclosure. Additionally, some exemplary embodiments of featuresthat can be incorporated into the handle assembly 12 are provided for inpatents and patent applications incorporated by reference elsewhere inthe present application.

The shaft 14 can be removably coupled to the distal end 12 d of thehandle assembly 12 at a proximal end 14 p of the shaft 14, and a distalend 14 d of the shaft 14 can be configured to receive the attachmentportion 16. As shown, the shaft 14 is generally cylindrical andelongate, although any number of shapes and configurations can be usedfor the shaft, depending, at least in part, on the configurations of theother instrument components with which it is used and the type ofprocedure in which the instrument is used. For example, in someembodiments, a distal end of one shaft can have a particularconfiguration for receiving certain types of end effectors, while adistal end of another shaft can have a different configuration forreceiving certain other types of end effectors. Components of the firingsystem, such as a control rod 32 (FIG. 2), can be disposed in the shaft14 so that the components can reach the end effector 50 and driveassembly 80 to provide actuation of the same. For example, when thetrigger 20 operates the firing system, the control rod 32 can beadvanced distally through at least a portion of the shaft 14 to causethe jaws 52, 54 to collapse towards each other and/or to drive the driveassembly 80 distally through at least a portion of the end effector 50.

The shaft 14 can also include one or more sensors (not shown) andrelated components, such as electronic components to help operate anduse the sensors (not shown). The sensors and related components can beconfigured to communicate to a clinician the type of end effectorassociated with the distal end 14 d of the shaft 14, among otherparameters. Likewise, the handle assembly 12 can include one or moresensors and related components configured to communicate to a clinicianthe type of end effector and/or shaft associated with the distal end 12d of the handle assembly 12. Accordingly, because a variety of shaftscan be interchangeably coupled with the handle assembly 12 and a varietyof end effectors having different configurations can be interchangeablycoupled with various shafts, the sensors can help a clinician know whichshaft and end effector are being used. Additionally, the informationfrom the sensors can help a monitoring or control system associated withthe instrument know which operation and measurement parameters arerelevant to a clinician based on the type of shaft and end effectorcoupled to the handle assembly. For example, when the end effector is astapler, information about the number of times the drive assembly 80 isfired may be relevant, and when the end effector is another type of endeffector, such as a cutting device, the distance the cutting portiontraveled may be relevant. The system can convey the appropriateinformation to the clinician based on the end effector that is sensed.

A person skilled in the art will recognize that various configurationsof monitoring and control systems can be used in conjunction with thesurgical instruments provided herein. For example, sensors associatedwith any of the end effector 50, the attachment portion 16, the shaft14, and the handle assembly 12 can be configured to monitor other systemparameters, and a monitoring or control system can communicate to aclinician the relevant other parameters based on the type of shaft orattachment portion associated with the handle assembly. Further detailsabout sensors and related components, as well as monitoring and controlsystems, can be found in patents and patent applications incorporated byreference elsewhere in the present application.

As shown in FIG. 3, the attachment portion 16 can include a proximalhousing portion 34 at a proximal end 16 p thereof and an end effector ortool 50 at a distal end 16 d thereof. In the illustrated embodiment, theproximal housing portion 34 includes on a proximal end 34 p thereofengagement nubs 36 for releasably engaging the shaft 14. The nubs 36form a bayonet type coupling with the distal end 14 d of the shaft 14.Besides nubs 36, any number of other complementary mating features canbe used to allow the attachment portion 16 to be removably coupled tothe shaft 14.

A distal end 34 d of the proximal housing portion 34 can include amounting assembly 40 pivotally secured thereto. As shown in FIG. 4, themounting assembly 40 can be configured to receive a proximal end 50 p ofthe end effector 50 such that pivotal movement of the mounting assembly40 about an axis perpendicular to the longitudinal axis of the housingportion 34 effects articulation of the end effector 50 about a pivotmember or pin 42. This pivotal movement can be controlled by theactuation lever 26 of the handle assembly 28, with components beingdisposed between the lever 26 and the mounting assembly 40 to allow formovement of the lever 26 to articulate the mounting assembly 40, andthereby the end effector 50. Similar to the firing system of theinstrument 10, a person skilled in the art will recognize variousconfigurations of components for effecting articulation, mechanical orotherwise, and thus a detailed explanation of the same is unnecessary.Some exemplary embodiments of components for effecting articulation thatare suitable for use with the disclosures herein are provided for inpatents and patent applications incorporated by reference elsewhere inthe present application.

The end effector 50 of the illustrated embodiment is a surgical staplingtool having a first, lower jaw 52 that serves as a cartridge assembly orcarrier and an opposed second, upper jaw 54 that serves as an anvil. Asshown in FIG. 6, an inner surface 58 of the second jaw 54, sometimesreferred to as an anvil portion, can include a plurality of stapledeforming cavities 60 and a cover plate 62 secured to a top surface 59of the jaw 54 to define a cavity 64 therebetween. The cover plate 62 canhelp to prevent pinching of tissue during clamping and firing of thesurgical stapler. The cavity 64 can be dimensioned to receive a distalend 80 d of the axial drive assembly 80. A longitudinal slot 66 canextend through the anvil portion 58 to facilitate passage of a retentionflange 82 of the axial drive assembly 80 into the anvil cavity 64. Acamming surface 57 formed on the anvil portion 58 can be positioned toengage the axial drive assembly 80 to facilitate clamping of tissue 99.A pair of pivot members 53 formed on the anvil portion 54 can bepositioned within slots 51 formed in the carrier 52 to guide the anvilportion between the open and clamped positions. A pair of stabilizingmembers can engage a respective shoulder 55 formed on the carrier 52 toprevent the anvil portion 54 from sliding axially relative to the staplecartridge 100 as the camming surface 57 is deformed. In otherembodiments, the carrier 52 and staple cartridge 100 can be pivotedbetween open and clamped positions while the anvil portion 54 remainssubstantially stationary.

The elongated support channel 56 of the first jaw 52 can be dimensionedand configured to receive a staple cartridge 100, as shown in FIGS. 4,5, and 7. Corresponding tabs 102 and slots 68 formed along the staplecartridge 100 and the elongated support channel 56, respectively,function to retain the staple cartridge 100 within the support channel56. A pair of support struts 103 formed on the staple cartridge 100 canbe positioned to rest on sidewalls of the carrier 52 to furtherstabilize the staple cartridge 100 within the support channel 56. Thestaple cartridge 100 can also include retention slots 105 for receivinga plurality of fasteners 106 and pushers 108. A plurality of spacedapart longitudinal slots 107 can extend through the staple cartridge 100to accommodate upstanding cam wedges 70 of an actuation sled 72 of afiring system (FIGS. 4 and 8). A central longitudinal slot 109 canextend along the length of the staple cartridge 100 to facilitatepassage of a knife blade 81 associated with the axial drive assembly 80.During operation of the surgical stapler, the actuation sled 72translates through longitudinal slots 107 of the staple cartridge 100 toadvance cam wedges 70 into sequential contact with pushers 108, therebycausing the pushers 108 to translate vertically within the retentionslots 105 and urge the fasteners 106 from the slots 105 into the stapledeforming cavities 60 of the anvil portion 54.

An alternative embodiment of an attachment portion 16′ is shown in FIGS.9 and 10. The attachment portion 16′ can include a proximal housingportion 34′ at a proximal end 16 p′ thereof and an end effector or tool50′ at a distal end 16 d′ thereof. Nubs 36′ can be provided to removablycouple the attachment portion 16′ to a shaft of a surgical instrument,and a mounting assembly 40′ can be provided to removably and/orpivotally couple an end effector or tool 50′ to the proximal housingportion 34′. The end effector 50′ can include a first, lower jaw 52′that serves as a cartridge assembly, and a second, upper jaw 54′ thatserves as an anvil portion. The first jaw 52′ can have many of the samefeatures as the first jaw 52 of FIGS. 3, 4, and 6, and thus can includean elongated support channel 56′ that is dimensioned and configured toreceive a staple cartridge 100′, and slots 68′ configured to correspondwith tabs 102′ of the staple cartridge 100′ to retain the cartridge 100′within the channel 56′. Likewise, the cartridge 100′ can include supportstruts 103′ to rest on sidewalls of the jaw 52′, retention slots 105′for receiving a plurality of fasteners 106′ and pushers 108′, aplurality of spaced apart longitudinal slots 107′ to accommodateupstanding cam wedges 70′ of an actuation sled 72′ of a firing system,and a central longitudinal slot 109′ to facilitate passage of a knifeblade 81′ associated with an axial drive assembly 80′.

Similar to the second jaw 54 of FIGS. 3, 4, and 6, the second jaw 54′can include a cover plate 62′ secured to a top surface of the jaws todefine a cavity therebetween. An anvil plate 58′ can serve as the innersurface of the jaw 54′, and can include a longitudinal slot 66′ forreceiving a distal end of the axial drive assembly 80′, and a pluralityof staple deforming pockets or cavities (not shown) to form staplesejected from the cartridge 100′. In this embodiment, however, the lowerjaw 52′ containing the cartridge 100′ is configured to pivot toward theupper jaw 54′ while the upper jaw 54′ remains substantially stationaryupon actuation by a handle assembly and related components.

The end effector and staple cartridge disposed therein is configured toreceive an axial drive assembly. One non-limiting exemplary embodimentof the axial drive assembly 80 is illustrated in FIG. 11. As shown, adistal end of a drive beam 84 can be defined by a vertical support strut86 that supports the knife blade 81, and an abutment surface 88configured to engage the central portion of the actuation sled 72 duringa stapling procedure. Bottom surface 85 at the base of the abutmentsurface 88 can be configured to receive a support member 87 slidablypositioned along the bottom of the staple cartridge 100 (FIGS. 4 and 6).The knife blade 81 can be positioned to translate slightly behind theactuation sled 72 through the central longitudinal slot 109 in thestaple cartridge 100 to form an incision between rows of stapled bodytissue. The retention flange 82 can project distally from the verticalstrut 86 and can support a cylindrical cam roller 89 at its distal end.The cam roller 89 can be dimensioned and configured to engage thecamming surface 57 on the anvil portion 58 to clamp the anvil portion 58against body tissue. A person skilled in the art will recognize that adrive assembly for use in conjunction with surgical staplers or othersurgical instruments can have many other configurations than the oneillustrated in FIG. 11, some of which are described in patents andpatent applications incorporated by reference elsewhere in the presentapplication. By way of non-limiting example, the drive assembly 80 caninclude a single drive beam, or any other number of drive beams, and thedistal end of the drive beam(s) can have any number of shapes that areconfigured for use in the end effector through which the drive assemblyis configured to travel.

In use, the surgical stapler can be disposed in a cannula or port anddisposed at a surgical site. A tissue to be cut and stapled can beplaced between the jaws 52, 54 of the surgical stapler 10. Features ofthe stapler 10, such as the rotating knob 24 and the actuation lever 26,can be maneuvered as desired by the clinician to achieve a desiredlocation of the jaws 52, 54 at the surgical site and the tissue withrespect to the jaws 52, 54. After appropriate positioning has beenachieved, the trigger 20 can be pulled toward the stationary handle 22to actuate the firing system. The trigger 20 can cause components of thefiring system to operate such that the control rod 32 advances distallythrough at least a portion of the shaft 14 to cause at least one of thejaws 52, 54 to collapse towards the other to clamp the tissue disposedtherebetween and/or to drive the drive assembly 80 distally through atleast a portion of the end effector 50.

In some embodiments, a first firing of the trigger 20 can cause the jaws52, 54 to clamp the tissue, while subsequent firings of the trigger 20can cause the drive assembly 80 to be advanced distally through at leasta portion of the end effector 50. A single, subsequent firing can fullyadvance the drive assembly 80 through the staple cartridge 100 to ejectthe staples in the row, or alternatively, the components in the handleassembly 12 can be configured such that multiple, subsequent firings arerequired to fully advance the drive assembly 80 through the staplecartridge 100 to eject the staples in the row. Any number of subsequentfirings can be required, but in some exemplary embodiments anywhere fromtwo to five firings can fully advance the drive assembly 80 through thestaple cartridge 100. In embodiments in which the drive assembly 80includes the knife 81 to cut the tissue being stapled, the knife 81 cutstissue as the drive assembly advances distally through the end effector50, and thus the staple cartridge 100 disposed therein. In otherexemplary embodiments, a motor disposed within the handle assembly 12and associated with a firing trigger can actuate the drive assembly 80automatically in response to activation of the firing trigger.

After the drive assembly 80 has been advanced distally through thestaple cartridge 100, the retraction knobs 28 can be advanced proximallyto retract the drive assembly 80 back towards its initial position. Insome configurations, the retraction knobs 28 can be used to retract thedrive assembly 80 prior to fully advancing the assembly 80 through thecartridge 100. In other embodiments retraction of the drive assembly 80can be automated to occur after a predetermined action. For example,once the drive assembly 80 has distally advanced to its desiredlocation, the subsequent return of the trigger 80 back to a biased openposition can cause the drive assembly 80 to automatically retract. Amotor and associated components, rather than retraction knobs 28 andassociated components, can be used to retract the drive assembly 80.Further, as discussed above, other features, such as a firing lockoutmechanism, an anti-reverse clutch mechanism, and an emergency returnbutton, can be relied upon during operation of the surgical stapler 10,as would be understood by those skilled in the art.

The illustrated embodiment of a surgical stapling instrument 10 providesone of many different configurations, and associated methods of use,that can be used in conjunction with the disclosures provided herein.Additional exemplary embodiments of surgical staplers, componentsthereof, and their related methods of use, that can be used inaccordance with the present disclosure include those devices,components, and methods provided for in U.S. Patent ApplicationPublication No. 2012/0083835 and U.S. Patent Application Publication No.2013/0161374, each of which is incorporated by reference herein in itsentirety.

Implantable Materials

Regardless of the configuration of the surgical instrument, the presentdisclosure provides for the use of implantable materials, e.g., biologicmaterials and/or synthetic materials, collectively “adjunct materials,”in conjunction with instrument operations. As shown in FIGS. 12 and 13,the end effector 50 can include at least one piece of adjunct material200, 200′ positioned intermediate the first and second jaw members 52,54 and it can be releasably retained to one of the support channel 56and/or the anvil portion 58. In the illustrated embodiment, thereleasable retention is provided by retention members 202, 202′, whichare described in further detail below. In at least one embodiment, asurface on the adjunct material 200, 200′ can be configured to contacttissue as the tissue is clamped between the first and second jaw members52, 54. In such an embodiment, the adjunct material can be used todistribute the compressive clamping force over the tissue, remove excessfluid from the tissue, and/or improve the purchase of the staples. Invarious embodiments, one or more pieces of adjunct material can bepositioned within the end effector 50. In at least one embodiment, onepiece of adjunct material 200 can be attached to the staple cartridge100 (FIG. 12) and one piece of adjunct material 200′ can be attached tothe anvil portion 58 (FIG. 13). In at least one other embodiment, twopieces of adjunct material 200 can be positioned on the support channel56 and one piece of adjunct material 200′ can be positioned on the anvilportion 58, for example. Any suitable number of adjunct materials can besituated within the end effector 50.

Adjunct material used in conjunction with the disclosures provided forherein can have any number of configurations and properties. Generally,they can be formed from of a bioabsorbable material, a biofragmentablematerial, and/or a material otherwise capable of being broken down, forexample, such that the adjunct material can be absorbed, fragmented,and/or broken down during the healing process. In at least oneembodiment, the adjunct material can include a therapeutic drug that canbe configured to be released over time to aid the tissue in healing, forexample. In further various embodiments, the adjunct materials caninclude a non-absorbable and/or a material not capable of being brokendown, for example. Similarly, the connection or retention members can beat least partially formed from at least one of a bioabsorbable material,a biofragmentable material, and a material capable of being broken downsuch that the connection or retention members can be absorbed,fragmented, and/or broken down within the body. In various embodiments,the connection or retention members can include a therapeutic drug thatcan be configured to be released over time to aid the tissue in healing,for example. In further various embodiments, the connection or retentionmembers can include a non-absorbable and/or a material not capable ofbeing broken down, for example, such as a plastic.

More particularly, some exemplary, non-limiting examples of syntheticmaterials that can be used in conjunction with the disclosures providedfor herein include biodegradable synthetic absorbable polymer such as apolydioxanone film sold under the trademark PDS® or with a Polyglycerolsebacate (PGS) film or other biodegradable films formed from PGA(Polyglycolic acid, marketed under the trade mark Vicryl), PCL(Polycaprolactone), PLA or PLLA (Polylactic acid), PHA(polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under thetrademark Monocryl), PANACRYL (Ethicon, Inc., Somerville, N.J.),Polyglactin910, Poly glyconate, PGA/TMC (polyglycolide-trimethylenecarbonate sold under the trademark Biosyn), polyhydroxybutyrate (PHB),poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), or a blend ofcopolymerization of the PGA, PCL, PLA, PDS monomers. In use, thesynthetic material can be broken down by exposure to water such that thewater attacks the linkage of a polymer of the synthetic material. As aresult, the mechanical strength can become diminished, and a constructof the material can be broken down into a mushy or fractured scaffold.As further breakdown occurs such that the material breaks intocarbohydrates and acid constituents, a patient's body can metabolize andexpel the broken down materials.

Some exemplary, non-limiting examples of biologic derived materials thatcan be used in conjunction with the disclosures provided for hereininclude platelet poor plasma (PPP), platelet rich plasma (PRP), starch,chitosan, alginate, fibrin, thrombin, polysaccharide, cellulose,collagen, bovine collagen, bovine pericardium, gelatin-resorcin-formalinadhesive, oxidized cellulose, mussel-based adhesive, poly (amino acid),agarose, polyetheretherketones, amylose, hyaluronan, hyaluronic acid,whey protein, cellulose gum, starch, gelatin, silk, or other materialsuitable to be mixed with biological material and introduced to a woundor defect site, including combinations of materials, or any materialapparent to those skilled in the art in view of the disclosures providedfor herein. Biologic materials can be derived from a number of sources,including from the patient in which the biologic material is to beimplanted, a person that is not the patient in which the biologicmaterial is to be implanted, or other animals.

Additional disclosures pertaining to synthetic or polymer materials andbiologic materials that can be used in conjunction with the disclosuresprovided herein can be found in U.S. Patent Application Publication No.2012/0080335, U.S. Patent Application Publication No. 2012/0083835, U.S.patent application Ser. No. 13/433,115, entitled “Tissue ThicknessCompensator Comprising Capsules Defining a Low Pressure Environment,”and filed on Mar. 28, 2012, U.S. patent application Ser. No. 13/433,118,entitled “Tissue Thickness Compensator Comprised of a Plurality ofMaterials,” and filed on Mar. 28, 2012, U.S. patent application Ser. No.13/532,825, entitled “Tissue Thickness Compensator Having ImprovedVisibility,” and filed on Jun. 26, 2012, U.S. patent application Ser.No. 13/710,931, entitled “Electrosurgical End Effector with TissueTacking Features,” and filed on Dec. 11, 2012, and U.S. patentapplication Ser. No. 13/763,192, entitled “Multiple ThicknessImplantable Layers for Surgical Stapling Devices,” and filed on Feb. 8,2013, each of which is incorporated by reference herein in its entirety.

In use, the adjunct material can come pre-loaded onto the device and/orthe staple cartridge, while in other instances the adjunct material canbe packaged separately. In instances in which the adjunct material comespre-loaded onto the device and/or the staple cartridge, the staplingprocedure can be carried out as known to those skilled in the art. Forexample, in some instances the firing of the device can be enough todisassociate the adjunct material from the device and/or the staplecartridge, thereby requiring no further action by the clinician. Inother instances any remaining connection or retention member associatingthe adjunct material with the device and/or the staple cartridge can beremoved prior to removing the instrument from the surgical site, therebyleaving the adjunct material at the surgical site. In instances in whichthe adjunct material is packaged separately, the material can bereleasably coupled to at least one of a component of the end effectorand the staple cartridge prior to firing the device. The adjunctmaterial may be refrigerated, and thus removed from the refrigerator andthe related packaging, and then coupled to the device using a connectionor retention member as described herein or otherwise known to thoseskilled in the art. The stapling procedure can then be carried out asknown to those skilled in the art, and if necessary, the adjunctmaterial can be disassociated with the device as described above.

Retention Members

Connection or retention members can be used to secure, at leasttemporarily, one or more pieces of adjunct material onto an end effectorand/or staple cartridge. These retention members can come in a varietyof forms and configurations, such as one or more sutures, adhesivematerials, staples, brackets, snap-on or other coupling or matingelements, etc. For example, the retention members can be positionedproximate to one or more sides and/or ends of the adjunct material,which can help prevent the adjunct material from peeling away from thestaple cartridge and/or the anvil face when the end effector is insertedthrough a trocar or engaged with tissue. In still other embodiments, theretention members can be used with or in the form of an adhesivesuitable to releasably retain the adjunct material to the end effector,such as cyanoacrylate. In at least one embodiment, the adhesive can beapplied to the retention members prior to the retention members beingengaged with the adjunct material, staple cartridge, and/or anvilportion. Generally, once firing is completed, the retention member(s)can be detached from the adjunct material and/or the end effector sothat the adjunct material can stay at the surgical site when the endeffector is removed. Some exemplary, non-limiting embodiments ofretention members are described herein with respect to FIGS. 12-15.

FIG. 12 illustrates one exemplary embodiment of a connection orretention member 202 associated with the adjunct material 200 to securethe material 200 at a temporary location with respect to the lower jaw52 of the end effector 50. As shown, the adjunct material 200 isdisposed over the staple cartridge 100 located in the elongate channel56 of the lower jaw 52, and the retention member 202 extendstherethrough. In the embodiment, the retention member 202 is in the formof a single suture stitched through multiple locations of the adjunctmaterial 200, or it can be multiple sutures disposed at one or morelocations on the adjunct material 200. As shown, the sutures arepositioned at locations around a perimeter of the adjunct material 200,and are also adjacent to a central longitudinal channel 201 formed inthe adjunct material 200. The channel 201 can make it easier for a knifepassing through the adjunct material 200 to cut the material 200 intotwo or more separate strips. In some embodiments, for instance when theretention member 202 is a single suture threaded through multiplelocations of the adjunct material 200, a knife passing through the lowerjaw 52 can cut the retention member 202 at one or more locations,thereby allowing the retention member 202 to be disassociated from theadjunct material 200 and removed from the surgical site while theadjunct material 200 remains held at the surgical site by one or morestaples ejected from the cartridge 100.

FIG. 13 illustrates another embodiment of a connection or retentionmember 202′ associated with the adjunct material 200′ to secure thematerial 200′ at a temporary location on the end effector 50. Theretention member 202′ has the same configuration as the retention member202 in FIG. 12, however, in this embodiment it is used to secure thematerial to the anvil or upper jaw 54, rather than the cartridge orlower jaw 52.

FIG. 14 illustrates another, non-limiting embodiment of a connection orretention member 202″ used to releasably retain an adjunct material 200″to at least one of the upper jaw 54 and the lower jaw 52. In thisembodiment, the retention member 202″ is a single suture that extendsthrough a distal portion 200 d″ of the adjunct material 200″ and iscoupled to a proximal end 54 p of the upper jaw 54. Terminal ends 202 t″of the retention member 202″ can be used to move the retention member202″ with respect to the jaws 54, 52. In its extended position, which isillustrated in FIG. 14, the retention member 202″ can hold the adjunctmaterial 200″ in position as the end effector 50 is inserted into asurgical site. Thereafter, the jaws 52, 54 of the end effector 50 can beclosed onto tissue, for example, and staples from the staple cartridge100 can be deployed through the adjunct material 200″ and into thetissue. The retention member 202″ can be moved into its retractedposition such that the retention member 202″ can be operably disengagedfrom the adjunct material 200″. Alternatively, the retention member 202″can be retracted prior to the staples being deployed. In any event, as aresult of the above, the end effector 50 can be opened and withdrawnfrom the surgical site leaving behind the adjunct material 200″ andtissue.

FIG. 15 illustrates yet another, non-limiting embodiment of a connectionor retention member 202′″ for securing a location of adjunct material200′″ to an end effector. In particular, the adjunct material 200′″ andretention member 202′″ are used in conjunction with the end effector 50′of FIGS. 9 and 10. In this embodiment, the retention member 202′″ is inthe form of a suture that is used to tie the adjunct material 200′″ tothe first, lower jaw 52′ at proximal and distal ends thereof 52 p′, 52d′. Similarly, as shown in FIGS. 9 and 10, the adjunct material 200′″can also be secured to the second, upper jaw 54′ at proximal and distalends thereof 54 p′, 54 d′. Optionally, recesses can be formed in eitheror both of the jaws 52′, 54′, and either or both of the adjunctmaterials 200′″, which can protect the retention members 202′″ againstunintended cutting by an outside object. In use, the knife blade 81′ onthe driver assembly 80′ can incise the retention members 202′″ as itpasses through the end effector 50′ to release the adjunct material200′″.

A person skilled in the art will recognize a variety of other ways bywhich the adjunct material can be temporarily retained with respect tothe end effector. In various embodiments a connection or retentionmember can be configured to be released from an end effector anddeployed along with a piece of adjunct material. In at least oneembodiment, head portions of retention members can be configured to beseparated from body portions of retention members such that the headportions can be deployed with the adjunct material while the bodyportions remain attached to the end effector. In other variousembodiments, the entirety of the retention members can remain engagedwith the end effector when the adjunct material is detached from the endeffector.

Tissue Ingrowth Materials

As indicated above, various adjunct materials are provided for use witha surgical stapler. While in some instances the adjunct materials can bea synthetic material and/or a biologic material, in some exemplaryembodiments the adjunct material can be especially configured tofacilitate tissue ingrowth into the materials. While this can beachieved using various techniques, in one embodiment the adjunctmaterial can include both hydrophilic portions and hydrophobic portionsto form a hydrophilic-hydrophobic adjunct material. The resultingcombination can advantageously have surfaces or portions that attractcells and encourage cell ingrowth (hydrophilic) and surfaces or portionsthat do not attract cells or otherwise encourage cell ingrowth(hydrophobic). In use, the hydrophobic portions can be placed in contactwith the tissue, while the hydrophobic portions can be oriented awayfrom the tissue surface.

In certain embodiments, synthetic polymers used to form adjunctmaterials can be hydrophobic, such as polycaprolactone (PCL) andpolylactic acid (PLLA). It is noted that “polymers” as used herein caninclude copolymers. Synthetic adjunct materials, however, can be treatedor otherwise produced to be hydrophilic, as will be discussed herein. Toform the adjunct material, any method of creating a synthetic materialhaving a hydrophilic portion and a hydrophobic portion can be used. Insome embodiments, a surface of (or only half of) a hydrophobic adjunctmaterial is treated with an acid or base which can cause the formationof pockets or pits in the surface. Alternatively, the adjunct materialcan be formed by bonding a hydrophilic layer to a hydrophobic layer. Forexample, an adjunct material can be treated such that the entire adjunctmaterial becomes hydrophilic. Then this hydrophilic layer can be bound,such as by laminating, to a second hydrophobic adjunct material layercreating a material that is hydrophobic and hydrophilic. Variousapproaches can be used to create an adjunct material or matrix where atissue contacting portion encourages cellular ingrowth while anon-tissue contacting portion discourages cellular ingrowth.

Any adjunct material, such as those described above, can be madehydrophilic and/or hydrophobic. Additionally, a person skilled in theart will appreciate that any form of adjunct material can be made to behydrophilic and/or hydrophobic, for example a film type adjunct materialand/or a foam type adjunct material. In one exemplary embodiment, a filmor foam can be made hydrophilic using any suitable technique, such assurface grafting techniques and coating techniques, depending upon thephysical or chemical characteristics of the film or foam.

Surface grafting techniques can be employed, for example, if the film orfoam has reactive chemical sites or functionalities such as amino,hydroxyl or carboxyl groups. If this is the case, the film or foam canbe made hydrophilic by covalently binding hydrophilic moieties orsurfactants onto the film or foam. These hydrophilic moieties caninclude, but are not limited to, polyethylene glycol (PEG) andpoloxamers (available under the trade names Pluronic® available fromBASF, Synperonic® available from Sigma Aldrich, and Kolliphor availablefrom BASF).

Coating techniques can be used, for example, if the film or foam doesnot have any reactive sites as it will generally not be possible toimpart the hydrophilic characteristics using surface grating techniques.Various levels of coating with a hydrophilic polymer will impart varyingdegrees of hydrophilicity to the foam or film. However, care needs to betaken in the case of porous foam since coating can result in closing ofthe open pores and may result in conversion of open cell or reticulatedfoam to closed cell foam.

In one embodiment, hydrophilic 65:35 PGA/PCL polymers can be prepared bycopolymerizing PEG/Pluronic with PCL/PGA. Introduction of PEG orpoloxamer repeat units in the copolymer backbone can render the backbonehydrophilic resulting in swelling upon contact with body fluidsincluding blood. The hydrophilicity of the polymer can be controlled byusing various molecular weights of PEG and poloxamers and the ratio ofPEG/poloxamer to PCL/PGA. For example, higher content of PEG/poloxameris expected to result in higher swelling and higher hydrophilicity.

An adjunct material can be selectively attached to either or both jawsof an end effector. As shown in FIG. 16, an adjunct material 400, 400′can be attached to both lower and upper jaws 1052, 1054 of an endeffector 1050. The adjunct material 400, 400′ can have a first side 402,402′ that is hydrophobic and a second side 404, 404′ that ishydrophilic. The first, hydrophobic side 402, 402′ can be configured toface and directly contact the upper and lower jaws 1052, 1054, while thesecond, hydrophilic side 404, 404′ can be oriented away from the upperand/or lower jaws 1052, 1054. In this configuration, the secondhydrophilic side 404, 404′ will face and directly contact the tissuebeing treated (i.e., grasped by the end effector 1050) once the endeffector 1052 is actuated, and the first, hydrophobic side 402, 402′will be on an opposite side facing away from the tissue being treated orgrasped. This configuration is illustrated in FIGS. 18A and 18B, as willbe discussed in detail below.

FIGS. 17A-17C illustrate the adjunct material 400, 400′ when wetted by adrop of water 406. As shown, the hydrophilic side 404, 404′ absorbs thewater 406 and disperses the water 406 through the layer 404, 404′. Incontrast, the hydrophobic side 402, 402′ repels the water 406, whichremains substantially on the surface of the hydrophobic layer 402, 402′.

In use, the adjunct material 400 can be positioned in a body, such as isshown in FIGS. 18A and 18B. As shown in FIG. 18A, the adjunct material400 is implanted at a treatment site using staples 408 such that thehydrophilic side 404 of the adjunct material 400 is directly contactingthe tissue to be treated 410 and the hydrophobic side 402 on an oppositeside and is exposed to an adjacent tissue 412, such as an organ wheretissue ingrowth is not desired. In this configuration, the hydrophilicside 404 enhances cellular ingrowth into the grasped tissue 410 and thehydrophobic side 402 discourages cellular ingrowth and thereforeprevents the hydrophobic side from attaching to adjacent tissue 412.FIG. 18B illustrates this further as the hydrophilic side 404 is incontact with the tissue to be treated 410, but not the adjacent tissue412 and the hydrophobic side is in contact with the adjacent tissue 412,but not the tissue to be treated 410.

Biologically Coated Synthetic Materials

As mentioned above, typically synthetic absorbable materials arehydrophobic and at best do not inhibit healing and at worst are treatedlike foreign bodies during healing. It is possible, however, to take ahydrophobic matrix, like PGA/PCL, and micro-etch or pit the surface ofthe polymer to make the material more hydrophilic. Once etched orpitted, it is further possible to deposit or coat the syntheticabsorbable material with a biologic material, such as collagen orfibrin, so as to form an synthetic absorbable material that has abiologic coating, which enhances healing as a biologic but retains thestructural properties of the synthetic absorbable material.

FIGS. 19A-19C illustrate various synthetic absorbable materials havingsurface features and characteristics, such as nanofeatures, that createa macro-structure that has the effect of creating a hydrophilic surfacethus allowing for biologic coating. FIG. 19A depicts an adjunct materialthat is woven 500. The woven material creates surface features 502,i.e., pockets, that can entrap a biologic. Additionally, the wovenadjunct material 500 can be formed of fibers 504 that are eitherhydrophilic or hydrophobic, or combinations thereof, which allow thewoven material to be an hydrophilic-hydrophobic material, as well asenables it to have a biologic coating. FIG. 19B depicts a syntheticabsorbable material 500′ that has micro-etched surface features 502′that are produced using a laser etching technique. These surfacefeatures 502′ similarly provide hydrophilic surface features on thesynthetic absorbable material. FIG. 19C illustrates a syntheticabsorbable material 500″ that has been treated with a surface hydrolysistechnique. This surface hydrolysis can be done through introduction of astrong acid or base that is then washed off or freeze dried away beforeit destroys the entire matrix. This surface hydrolysis results insurface pitting forming a macro-structure that creates a hydrophilicsurface and thus encourages cellular ingrowth. Likewise weaving, laseretching, surface coating, plasma treatment, surface grafting, and/orblending can be done to improve the hydrophilic properties of thesynthetic absorbable material. These surface etching and pittingtechniques can not only make the adjunct material (or scaffold)hydrophilic, it can leave pitted surfaces that retain fluids once theyare encourage to move into the structure.

FIGS. 20A-20C are scanning electron microscope images of syntheticabsorbable materials 600, 600′, 600″ having surface pitting 602, 602′,602″. FIGS. 21A-21C are scanning electron microscope images of syntheticabsorbable materials 700, 700′, 700″ having micro-etched nanofeatures702, 702′, 702″ on their surface. As shown in FIGS. 21B and 21C, cells704 adhere or attach to the nanofeatures 702′, 702″ and thus encouragecellular ingrowth. FIGS. 22A-22C illustrate additional surface features,i.e., function groups, 802, 802′, 802″ that can be formed on syntheticabsorbable material 800, 800′, 800″ using plasma etching and/or polymeretching techniques. FIG. 22A shows the result of plasma etching and/orpolymer grafting that occurs when oxidation in air occurs, FIG. 22Bshows that hydroxyl groups 802′ are formed when an aldehyde is used, andFIG. 22C shows that amine groups 802″ are formed when diamines andblending are used.

Coating the micro-etched or pitted synthetic absorbable material can beachieved by any suitable method. For example, once the pitted or etchedsurface is formed, it can be saturated with a liquified collagen,fibrin, or other biologic material. Following saturation, the saturatedsynthetic absorbable adjunct material or scaffold can then be freezedried or lyophilized to create a biologic surface coating that will beretained in the pits even after hydrating the adjunct material orscaffold. This biologically coated synthetic material can act like abiologic to in growing cells while still retaining desired syntheticproperties, as discussed above.

Tissue Reinforcement Materials with Sealing Properties

The tissue reinforcement materials described herein can be embodied in avariety of different materials, including adjunct materials. While invarious instances adjunct materials can be either a synthetic materialor a biologic material, in various embodiments the adjunct materialincludes both synthetic material and biologic material (i.e., it is ahybrid adjunct material). The resulting combination can advantageouslyexhibit beneficial features from both types of materials in a singlehybrid material. For example, a hybrid adjunct material can be designedto combine benefits of biologic material (such as improved healing andtissue growth) with desirable mechanical properties of syntheticmaterial (such as elasticity or the ability to provide compression). Invarious embodiments, a synthetic material can also provide structure andsupport for a biologic material (e.g., add strength and/or shearresistance to fibrous biologic material), while still allowing thebiologic material to contact a surgical site and support and/or promotehealing. Further, hybrid adjunct materials can be configured to helpreduce inflammation, promote cell growth, and/or otherwise improvehealing. In various embodiments, adjunct material can be bioimplantableand/or bioabsorbable.

FIGS. 23-23C illustrate several views of an exemplary tissuereinforcement material having a plurality of fibers in a loop structurearrangement.

FIGS. 23 and 23A, show one exemplary tissue reinforcement material 1601in accordance with the present disclosure. Here, the tissuereinforcement material 1601 is releasably retained on a portion of asurgical stapler end effector (see, e.g., FIGS. 1 and 10), shown in partby an anvil or upper jaw 1602, for delivery to tissue upon deployment ofstaples. The tissue reinforcement material 1601 includes a plurality offibers 1603 having an arrangement configured to compress and seal arounda fastener component (e.g., a surgical staple) inserted therethrough.One skilled in the art will appreciate that such compression and sealingproperties can be beneficial in that they can prevent fluid (e.g.,blood) leakage from around a staple leg. In this example, thearrangement is a loop structure of fibers, shown in further detail inmagnified fibers 1603′. The fibers 1603, 1603′ form the loop structurethrough the intertwining of the fibers 1603, 1603′.

FIG. 23C illustrates a single strand of fiber 1604 in a loop structure.In this example, the fiber 1604 was contacted with a liquid or gel anddried to form a membrane 1605 extending around the fiber 1604 andbetween loops in the fiber 1604. FIG. 23C illustrates a cross section AAtaken along the plane AA in FIG. 23B, where the fiber 1604 is embeddedin the membrane 1605. The fiber 1604 can be intertwined or woven withother fibers, or another portion of the same fiber 1604, to achieve thedesired sealing properties.

While FIGS. 23 and 23A illustrate a particular loop structure of fibers1603, 1603′, and FIGS. 23B and 23C illustrate a particular singlestrand, a person skilled in the art will appreciate that a plurality offibers can be arranged in number of alternative structures having anarrangement configured to compress and seal around a fastener componentinserted therethrough (which may also be a function of other features orcomponents of the tissue reinforcement material). Examples ofalternative structures include weaves, interlocking and interconnectingpatterns, as well as different loop structures. Exemplary patterns canin include two or more loop or weave structures. Likewise, patterns caninclude two or more types of fibers. Arrangements can be configured toallow the material to stretch and recover in response to penetration bya fastener component. Similarly, the plurality of fibers can be elastic.In various embodiments, the arrangement can advantageously provide abiologic material (e.g., woven biologic) with a desirable mechanicalproperties of a synthetic material.

FIGS. 24A and 24B illustrate exemplary fiber arrangements configured tocompress and seal around a fastener component (e.g., surgical staple)inserted therethrough. In these examples, the woven material 1700, 1700′includes a plurality of fibers 1701, 1701′ having an intertwined loopstructure arrangement. Dashed circle 1702, 1702′ indicates a region ofthe woven material 1700, 1700′ through which a fastener component (e.g.,surgical staple) will be inserted. A person skilled in the art willrecognize that while woven material 1700, 1700′ has an essentiallyuniform arrangement, alternative materials having different patterns(e.g., a denser weave at a region through which a fastener componentwill be inserted) are encompassed by the present disclosure. Asillustrated when a fastener component such as a staple leg 1703, 1703′is inserted through the woven material 1700, 1700′, the weave in theregion 1704, 1704′ adjacent to the staple leg 1703, 1703′ is distorted,for example through tightening and/or swelling, thereby sealing aroundthe staple leg 1703, 1703′.

FIGS. 24A and 24B also illustrate that different types of fibers (e.g.,in addition to different types of arrangements) can be employed toachieve the desired mechanical properties. For example, FIG. 24A shows anarrower, filamentous fiber 1701 as compared to FIG. 24B, which shows athicker, textured fiber 1701′. As a result, the region 1704′ adjacent tothe staple leg 1703′ in FIG. 24B exhibits greater tightening and/orswelling than region 1704 adjacent to the staple leg 1703 in FIG. 24A.

A person skilled in the art will recognize that the fiber arrangementsshown in FIGS. 24A and 24B are non-limiting examples, and thatalternative materials having different fiber types and combinations arealso encompassed by the present disclosure. In various embodiments, theplurality of fibers include a biologic material. Further, in variousembodiments, the plurality of fibers include a synthetic material. Insome embodiments, the plurality of fibers includes both a biologicmaterial and a synthetic material. The fiber can be a woven, spun, cast,or extruded fiber.

FIG. 25 illustrates another exemplary embodiment 1800 of a tissuereinforcement material 1801 having vertical and radial springiness,which seals around a fastener 1802 inserted through the material 1801and tissue 1803 (e.g., biologic tissue at a surgical site). As shown inFIG. 25 the tissue reinforcement material 1801 has been released from aportion of a surgical stapler end effector (not shown) and delivered tothe tissue 1803 upon deployment of a staple 1802 from a surgical stapler(not shown). As shown, the tissue reinforcement material 1801 includes aplurality of fibers 1804 having an arrangement configured to compressand seal around the fastener 1802 inserted therethrough.

In contrast to the loop structure of fibers 1603, 1603′, 1604, 1701,1701′ shown in FIGS. 23A-C and 24A-B, which seal around a fastenercomponent largely through deformation, tightening, and/or swelling ofthe loop structure around the fastener component, the plurality offibers 1804 shown in FIG. 25 have a three dimensional network patternthat has vertical springiness 1805 and radial springiness 1806, whichseal around a fastener component 1802 largely through an elastic and/orspring force exerted by the fibers 1804 on the fastener component 1802.The vertical springiness 1805 and radial springiness 1806 of theplurality of fibers 1804 can be a result of the arrangement of fibers,the fiber material, or a combination thereof. A person skilled in theart will appreciate that other arrangement of fibers that can exert anelastic and/or spring force on the fastener component are possible, andare not limited to the exemplary embodiments of FIG. 25. Fibers ofdifferent materials and/or arrangements can be used to providespringiness. For example, springiness can be achieved in a tissuereinforcement material using vertical standing loops made of arelatively hard or resilient material like polyglactin 910 (available asVICRYL™ manufactured by Ethicon, Inc.), and the rest of the tissuereinforcement material can be made of a biologic or a relatively softermaterial, like poliglecaprone 25 (available as MONOCRYL™ manufactured byEthicon, Inc.). The base of each standing loop can be knotted to aninterwoven substrate providing an anchor and therefore more column forceor springiness. In one embodiment, the standing fibers can also be wovenin a reversing pattern where every other fiber is at an opposite angle(e.g., plus and minus 30 degrees from vertical). In such a pattern,alternating fibers can cancel out each other's off angle, which allowsthem to lay down and therefore support an upper woven structure from alower structure in a truss format that provides vertical springiness.

Fibers can be selected based upon other physical properties. Forexample, in various embodiments, the material swells around the fastenercomponent when the fastener component is inserted therethrough, to forma seal around the fastener component. In various embodiments, thematerial swells around the fastener component when the second materialis wetted, to form a seal around the fastener component. In someembodiments, the material swells around the fastener component when thefastener component is inserted therethrough and when the material iswetted, to form a seal around the fastener component. Furthermore, invarious embodiments, the material engages the fastener component whenthe fastener component is inserted therethrough to mitigate movement ofthe material and tissue adjacent the fastener component, relative to thefastener component. Fibers and arrangements thereof can also providetissue reinforcement materials with other properties such asflexibility, an ability to stretch and recover, and/or an ability torelease or elute one or more biologically active agents (e.g., drugs).Fibers can be, or include, biologic fibers. A person skilled in the artwill recognize that the properties of the material (e.g., with respectto sealing) can be affected by components of the material in addition tothe fibers.

In various embodiments, the tissue reinforcement material includes abiologic material. Likewise, the tissue reinforcement material caninclude a synthetic material. In various embodiments, the tissuereinforcement material can be formed in a single layer. For example,like the embodiment illustrated in FIG. 23, the material can have asingle layer including the plurality of fibers. A single layer caninclude a biologic material and a plurality of fibers. In variousembodiments, the tissue reinforcement material can be formed in two ormore layers, e.g., as illustrated in FIGS. 30 and 31. For example, thematerial can have a first layer including a biologic material and asecond layer including the plurality of fibers. In various embodiments,the material is a hybrid adjunct material including a biologic materialand a synthetic material. It is understood that the biologic material ifpresent, can be in the form of a fiber or in another form, such as amembrane.

Tissue reinforcement materials can be made from essentially any biologicand/or synthetic material having the desired mechanical (e.g., sealing)and biologic (e.g., bioimplantable and bioabsorbable) properties.Representative examples are discussed in the IMPLANTABLE MATERIALSsection above. A person skilled in the art will appreciate that theshape of tissue reinforcement materials (and/or layers thereof) are notlimited to the parallelepiped or rhombohedron like forms shown in theillustrated examples. In various embodiments, hybrid adjunct materials(and layers thereof) are not necessarily symmetrical as shown in FIGS.23 and 25 and can, for example, vary in thickness or have irregularlyshaped portions.

As discussed above, FIG. 23 illustrates the tissue reinforcementmaterial 1601 in the context of a staple cartridge assembly 1600 for usewith a surgical stapler, which is another embodiment encompassed by thepresent disclosure. The assembly 1600 includes a tissue reinforcementmaterial 1601 and a cartridge body having a plurality of staple cavitiesconfigured to seat staples therein (see, e.g., FIGS. 4 and 10). Asdiscussed above, the tissue reinforcement material 1601 is releasablyretained on a portion of a surgical stapler end effector (see, e.g.,FIGS. 1 and 10), in this example shown in part by an anvil or upper jaw1602, for delivery to tissue upon deployment of staples. The tissuereinforcement material 1601 includes a plurality of fibers 1603 havingan arrangement (in this example, a loop structure) configured tocompress and seal around a fastener component inserted therethrough.

Here, the cartridge body and staples are encased by lower jaw of an endeffector of a surgical instrument (see, e.g., FIGS. 1 and 10). Thetissue reinforcement material 1601 is releasably retained on the anvilor upper jaw 1602 and configured to be delivered to tissue by deploymentof the staples from the cartridge body (discussed below). As will beunderstood by a person skilled in the art, numerous configurationsbeyond the example of FIG. 23 are possible. For example, tissuereinforcement material can be releasably retained on a staple cartridge,both a staple cartridge and an upper jaw of an end effector, a lower jawof an end effector, or on both upper and lower jaws of an end effector(see, e.g., FIGS. 31A-C).

A tissue reinforcement material can be releasably retained on a portionof a surgical stapler by retention members, which can come in a varietyof forms and configurations such as one or more sutures, adhesivematerials, staples, brackets, snap-on or other coupling or matingelements, and the like. Retention members are discussed in furtherdetail in the RETENTION MEMBERS section above. In various embodiments,the assembly includes at least one retention member configured to couplethe material to the cartridge body. The at least one retention member,which can include a suture, can be coupled to an outer edge of thecartridge body and an outer edge of at least one of the biologic tissuemembrane and the synthetic substrate layer.

In other aspects and embodiments, the disclosure also provides fortissue reinforcement materials that are releasably retained on a portionof a surgical stapler end effector for delivery to tissue upondeployment of staples, where the tissue reinforcement material has anarrangement (other than a loop structure of fibers) configured tocompress and seal around a fastener component inserted therethrough.FIG. 26 illustrates a perspective view of one such alternative endeffector component 1900, in which the tissue reinforcement material 1901includes a collagen matrix. Like the embodiment of FIG. 23, the tissuereinforcement material 1901 in FIG. 26 is releasably retained on anupper jaw 1902 of an end effector. However, as will be understood by aperson skilled in the art, numerous configurations beyond the example ofFIG. 26 are possible. For example, tissue reinforcement material can bereleasably retained on a staple cartridge, both a staple cartridge andan upper jaw of an end effector, a lower jaw of an end effector, or onboth upper and lower jaws of an end effector (see, e.g., FIGS. 31A-C).

As illustrated in FIG. 26, the tissue reinforcement material 1901includes a collagen matrix formed by molding, and then solidifying,aqueous collagen. For example, a collagen purification and refinementprocess can suspend collagen in an aqueous state. In this state, fatsand other impurities can be skimmed off, and the aqueous collagen can bepoured into a mold. As shown in FIG. 26, as well as the detailed crosssectional view of FIG. 27, the mold (not shown) has inverse pocketsallowing for the formation of a solid collagen matrix 1901 having abasic anvil pocket shape 1903 on a face 1905 of the matrix, which matesto corresponding pockets 1904 on the upper jaw 1902 of the end effector.The temperature and surface conditions of the mold can be tuned in orderto create a density variant around these inverse pocket shapes 1903, andonce solidified the inverse pocket shapes 1903 can be keyed intocorresponding pockets 1904 on the anvil or upper jaw 1902 of a staplecartridge. Alternatively, a similar method can be used to from a tissuereinforcement material from a thin film of 65/35 PGA/PCL, which in athin film can act as a semi-adhesive. The amount of PGA/PCL left on thecollagen after firing can be minimal.

When tissue reinforcement material 1901, or a similar material, iscompressed against tissue 1906 during clamping (i.e., between the upperjaw 1902 and lower jaw 1908 of an end effector) the main collagen body1901 and the pockets 1903 can be crushed, creating a layer that caneasily be penetrated by staples 1907 (e.g., from staple cartridge 1909)but can exclude tissue 1906 from the staple forming area (e.g., pocket1903), thereby minimizing staple damage to the tissue 1906 (e.g., ablood vessel) and therefore bleeding after stapling.

FIG. 28 illustrates a section 2100 of deployed tissue reinforcementmaterial, where materials and methods such as those illustrated in FIGS.23-27, can be modified by including a substance that swells in thepresence of liquids (e.g., hyrdrogel, oxidized regenerated cellulose(ORC), alginate, and the like). Swelling can aid in sealing around astaple leg 2101 inserted through tissue 2102 and a tissue reinforcementmaterial 2103, and in minimizing tissue damage. A person skilled in theart will appreciate that such swelling materials can include, or becombined with, other features and properties disclosed and discussedherein.

FIG. 29 illustrates an exemplary hybrid adjunct tissue reinforcementmaterial 2201 implanted at a surgical site 2200. Hybrid adjunctmaterials such as material 2201 can advantageously combine benefits ofbiologic materials and synthetic materials. For example, biologicadjunct matrices can create less inflammation response (i.e., incomparison to synthetic matrices), while retaining biologic growthfactors, chemical compounds, and/or hormones that can facilitatehealing. At a micro level however, biologic matrices, whether wet ordry, can be fibrous structures incapable of providing sufficientmechanical sealing (e.g., in demanding applications such as large vesseltransection). Hybrid adjunct materials such as material 2201 can, forexample, reduce leaking or bleeding (e.g., in a transected and stapledvessel) because hybrid adjunct materials can have the mechanicalstrength to keep the tissue out of the pocket staple forming area (e.g.,as described in connection with FIG. 27) as well as the ability to cincharound the staple legs, to restrict bleeding up the staple legs throughthe holes made by the staple legs.

In order to illustrate the mechanical properties of the hybrid adjunctmaterial 2201, the surgical site 2200 is shown with a first stapledregion 2202 lacking a tissue reinforcement material and a second stapledregion 2203 having a hybrid adjunct material 2201. At the first stapledregion 2202, a first staple 2204 has been inserted through tissue 2205,thus creating holes 2206 through tissue 2205. As a result, blood loss2207 can occur through the staple 2204 legs and through the holes 2206made by the staple 2204 legs.

In contrast, at the second stapled region 2203, a second staple 2208 hasbeen inserted through tissue 2205 as well as the hybrid adjunct material2201. As illustrated, the hybrid adjunct material 2201 includes abiologic outer tissue contacting layer 2209 that can be thin, resilient,and more elastic than a purely biologic fibrous matrix. The hybridadjunct material 2201 also includes a synthetic second layer 2210 thatis selected not necessarily for strength, spring back, or other grossmechanical reasons, but rather for micro staple interface reasons. Inorder to maintain the benefit of the biologic layer 2209, the thinsynthetic layer 2210 includes a mesh or variable thickness layer thatminimizes its interference in contact between the tissue 2205 and thebiologic layer 2209. The synthetic layer 2210 forms a seal around theleg of the second staple 2208, and prevents or mitigates blood 2211 fromleaking up the second staple 2208 legs through the holes 2212 made bythe second staple 2208 legs. In various embodiments the sealingproperties of the hybrid adjunct materials can result from a weave ofloop structure, a spring or compressive force, swelling, and the like. Aperson skilled in the art will appreciate that alternative hybridmaterials and hybrid adjunct materials can also be used in accordancewith the present disclosure. For example, the synthetic layer 2210 couldbe substituted for a biologic material providing the tissuereinforcement material with the desired mechanical properties.

FIGS. 30A-C illustrate different perspective views of an alternativeexemplary tissue reinforcement material 2300. Like the tissuereinforcement materials discussed and exemplified above, the tissuereinforcement material 2300 can be releasably retained on a portion of asurgical stapler end effector for delivery to tissue upon deployment ofstaples and can seal around a fastener component inserted therethrough.Likewise, the tissue reinforcement material 2300 can be part of a staplecartridge assembly.

With reference to FIG. 30A, the tissue reinforcement material 2300includes a top layer 2301, a bottom layer 2302, and one or morebuttresses 2303 having a surgical adhesive therein. The buttresses 2303can be arranged in a pattern, for example to complement a cartridge bodyhaving a plurality of staple cavities configured to seat staplestherein. That is, the buttresses 2303 can be aligned with the staplecavities, so that the staples are deployed through and puncture thebuttress, and the surgical adhesive seals around the staples andpunctures. Although buttresses are used in the embodiment of FIG. 30,other arrangements for providing surgical adhesive can be used. Forexample, a surgical adhesive can be uniformly sandwiched between top andbottom layers or within layer, or can be disposed within capsules (e.g.,similar to FIGS. 31A-C) on the surface of the top or bottom layer.Although the exemplary material illustrated in FIG. 30 uses a surgicaladhesive, it is understood that various other materials/fluids/gelshaving suitable properties can be used in addition or alternatively.

FIG. 30B shows a side view of the tissue reinforcement material 2300 ata buttress 2303, including a top layer of a buttress 2304, a bottomlayer of a buttress 2305, and a surgical adhesive 2306 disposedtherebetween. FIG. 30B shows a leg of a surgical staple 2307, which ispositioned to be deployed and puncture the buttress 2303. The fluid/gelproperties of a surgical adhesive can be preserved when sealed between atop layer of a buttress 2304 and a bottom layer of a buttress 2305.Similarly, the top and bottom layers 2304, 2305 can allow the surgicaladhesive to flow and achieve desired sealing effect after stapling. FIG.30C is an isometric view of the tissue reinforcement material 2300 afterdeployment of staples 2308 that puncture the buttress 2303. As shown,the surgical adhesive 2306 seals around the staples 2308 and puncturesin the buttress.

The top layer 2301 and bottom layer 2302 can comprise essentially any ofthe biologic and synthetic layers, absorbable polymer/polymer blends,gelatins, membranes, and matrices disclosed and described herein, aswell adjunct and hybrid adjunct materials. In various embodiments, thesurgical adhesive provides acts as a mechanical structure that sealsaround the fastener component (e.g., staple leg), and prevents leaks(e.g., of blood, air, GI fluids, and the like) at the surgical site.Furthermore, the tissue reinforcement material 2300 can providereinforcement and/or additional strength to tissue at a surgical site.

Examples of suitable materials for top and/or bottom layers include, butare not limited to, PLLA, PLGA, PCL, PGA, TMC, and associatedcopolymerizations. Examples of suitable materials/fluids/gels orsurgical adhesives include, but are not limited to biologically actives(e.g., freeze dried fibrin/thrombin powder, freeze dried fibrin/thrombinon a short fiber vicryl filament and/or ORC matrix), inertly actives(e.g., ORC fibers in a PCL/PGA liquid), viscous absorbables (e.g., 65/35PCL/PGA, 50/50 PCL/PGA, 50/50 PLLA/PCL, and the like), viscous urethanegels, and gelatinous absorbables (e.g., blends of copolymers orisomers). Examples of suitable film materials include, but are notlimited to PLLA, PLGA, PCL, PGA, TMC, associated copolymerizations, andthe like.

FIGS. 31A-C illustrate another alternative exemplary a tissuereinforcement material including a surgical adhesive that seals around afastener component.

With reference to FIG. 31A, a first tissue reinforcement material 2401is releasably retained on an anvil 2402 portion of a surgical staplerend effector 2400 for delivery to tissue upon deployment of staples, toseal around a fastener component inserted therethrough. The first tissuereinforcement material 2401 includes a first top layer 2403, a firstbottom layer 2404, and a first surgical adhesive 2405 disposedtherebetween. The anvil 2402 defines a plurality of pockets 2406, whichcorrespond to a first plurality of mating pocket shaped features 2407defined by the first tissue reinforcement material 2401 andencapsulating the first surgical adhesive 2405. In various embodiments,the plurality of pockets 2406 and corresponding plurality of matingpocket shaped features 2407 mediate, at least in part, the releasableretention of the material 2401 on the anvil 2402.

A second tissue reinforcement material 2411 is releasably retained on astaple cartridge 2412 portion of a surgical stapler end effector 2400for delivery to tissue upon deployment of staples, to seal around afastener component inserted therethrough. The second tissuereinforcement material 2411 includes a second top layer 2413, a secondbottom layer 2414, and a second surgical adhesive 2415 disposedtherebetween. The staple cartridge 2412 defines a plurality of pockets2416, which correspond to a plurality of mating pocket shaped features2417 defined by the second tissue reinforcement material 2411 andencapsulating the second surgical adhesive 2415. In various embodiments,the plurality of pockets 2416 and corresponding second plurality ofmating pocket shaped features 2417 mediate, at least in part, thereleasable retention of the material 2411 on the staple cartridge 2412.The staple cartridge 2412 has a plurality of staple cavities 2418configured to seat staples 2419 therein.

FIG. 31B illustrates an exploded view of a portion of the anvil 2402assembly and staple cartridge 2412, which provides additional detail onthe various features of the portion of a surgical stapler end effector2400, especially the pockets 2406, 2416, corresponding plurality ofmating pocket shaped features 2407, 2417, and their relative positioningto the staples 2419.

FIG. 31C illustrates an isometric view of the first tissue reinforcementmaterial 2401 and second tissue reinforcement material 2411 describedabove in connection with FIGS. 31A and 31B. This view focuses on thefeatures of the first and second top layers 2401, 2413, namely the firstand second plurality of mating pocket shaped features 2407, 2417. InFIG. 31C the second tissue reinforcement material 2411 is shown as beingpartially cutaway to illustrate the relative positioning of the secondplurality of mating pocket shaped features 2417.

A person skilled in the art will appreciate that various additionalembodiments in accordance with the disclosure can be provided by varyingthe number, location, composition, size, shape, etc. of the variouscomponents illustrated in FIGS. 31A-C. A number of representativecompositions and configurations, which can be used with the embodimentin FIGS. 31A-C, are discussed in the detailed description and exemplaryembodiments above.

FIGS. 31A-C show two film layers 2403, 2404 and 2413, 2414 with acaptured material 2405, 2415 (e.g., surgical adhesive) that can beviscous and/or reactive with body fluids, to seal around staples 2419like a needle in a rubber gasket. A viscous fluid can fill animperfection and/or tear in a film layer 2403, 2404, 2413, 2414 createdby a staple 2419 leg. Material 2405, 2415 can be a biologic such asfibrin, thrombin, calcium alginate, or cellulose (e.g., ORC, or oxidizedregenerated cellulose, which is a fiber in its solid non-reacted form).Material 2405, 2415 can also be a absorbable synthetic like 50/50PCL/PGA or 70/30 PCL/PGA, which remains a viscous fluid or semi-solid atbody temperature.

In another aspect, the disclosure provides a method for implanting atissue reinforcement material.

In another aspect, the disclosure provides methods for implanting atissue reinforcement material. FIGS. 32A-C illustrate an example of onesuch method. However, it is understood that this and other methodsprovided by the present invention are applicable to the use ofessentially any sealing tissue reinforcement materials in accordancewith the present invention.

FIG. 32A illustrates the engagement of tissue 2500 between a lower jaw2501 and an anvil or upper jaw 2502 of a surgical stapler at a surgicalsite. At least one of the lower jaw 2501 and upper jaw 2502 has a tissuereinforcement material 2503 releasably retained thereon. In thisexample, the lower jaw 2501 (e.g., through the cartridge assembly 2504)has a tissue reinforcement material 2503 releasably retained thereon.The material 2503 includes a plurality of fibers having an arrangementadapted to compress and seal around a fastener component insertedtherethrough (see, e.g., FIGS. 23-25 and alternative embodiments inFIGS. 26-31). Here, the tissue 2503 is engaged between an anvil or upperjaw 2502 and the lower jaw 2501, which encases the cartridge assembly2504 having staples 2505 disposed therein.

FIG. 32B illustrates an actuated surgical stapler that has ejectedstaples 2505 from the cartridge body 2504, and into the biologicaltissue 2500. The staples 2505 extend through the tissue reinforcementmaterial 2503 to maintain the material 2503 at the surgical site. Inthis example, actuation of the surgical stapler also cuts the tissue2503 at a surgical site between the staples 2505, as shown in FIG. 32B.Further embodiments and examples of such cutting embodiments aredescribed above. However, the present disclosure also contemplatesembodiments where tissue is not necessarily cut, or where tissue is notnecessarily cut concurrently with actuation of the surgical stapler.

FIG. 32C illustrates the tissue 2500 following deployment of staples2505 and tissue reinforcement material 2503. As shown, the staples 2505extend through the tissue reinforcement material 2503 and the tissue2500 to maintain the material 2503 at the surgical site. In thisillustration, the tissue 2500 comprising the staples 2505 is sealed andreinforced by the material 2503, thereby preventing or mitigatingtearing, fluid (e.g., blood), or other undesired damage to the surgicalsite. In various embodiments, it is only required that the material forma seal around the fastener component (e.g. staple leg). Avoidingundesired damage can decease surgical recovery time and mitigatesurgical complications. Furthermore, the reinforcement can promotehealing through the action of a biologic matrix in the material 2503and/or biologically active compounds therein. Similarly, thereinforcement can prevent or mitigate irritation and inflammation fromsynthetic material because any such synthetic can be internal to abiologic tissue membrane or matrix and/or because the syntheticessentially does not contact the tissue 2500. In alternativeembodiments, essentially all synthetic material can be encapsulated bybiologic material, to prevent or mitigate irritation and inflammationfrom synthetic material.

Positively Charged Synthetic Matrix

The retention members provided for herein, or other retention membersknown to those skilled in the art, can be used in conjunction with avariety of adjunct materials, such as adjunct materials 200, 200′, 200″,200′″ shown in FIGS. 12-15. While in some instances adjunct materials200, 200′, 200″, 200′″ can be a synthetic material, a biologic material,or a combination thereof, in some exemplary embodiments the adjunctmaterials can include synthetic material(s) having an electrical (e.g.,positive) charge.

Any adjunct material, or combination of adjunct materials, discussedherein can be configured to have such an electrical (e.g., positively)charge. In some embodiments, the adjunct material can be formed of asynthetic material that has positively charged polymers or copolymersand/or the adjunct material can be treated such that the polymer orcopolymers forming the adjunct material are substantially permanentlypositively charged. A skilled in the art will understand that adjunctmaterials having at least a portion of material that is positivelycharged can be formed of and/or used in combination with any other typeof adjunct material or matrix material—including but not limited tobiologic materials, synthetic materials, hydrophilic materials,hydrophobic materials, bioabsorbable materials, biofragmentablematerials, or combinations thereof.

The charged particles can be dispersed throughout the adjunct materialin any known manner. As used herein, “disperse” and conjugates thereofis used in its broadest sense to include distributed or spread over anarea, which can be uniform or not, as desired. By way of example, layershaving a uniform charge, or portions thereof having a charge, areconsidered to be dispersed, as well as discrete particles embedded in amaterial are dispersed. In some embodiments, for example, the chargedparticles can be dispersed throughout the entirety of the adjunctmaterial such as by treating the entirety of the adjunct material tohave a permanent positive charge—as is discussed below—or can be just onan outer surface of the adjunct material. Alternatively, portions of theadjunct material can be positively charged and distributed within or onthe adjunct material. For example, an adjunct material that is otherwiseuncharged can have a plurality of charged spheres or beads embedded orotherwise incorporated therein. Alternatively, a layer of positivelycharged synthetic material can be laminated onto or adjacent anuncharged layer of adjunct material. Additional embodiments can includea bioscaffold with a positive charge on the surface of fibers that formthe bioscaffold, and, alternatively, an extracellular matrix buttressmaterial having positively charged microspheres implanted therein. Asmentioned herein, adjunct material can include biologic materials,synthetic materials, hydrophilic materials, hydrophobic materials, orany other known material or combination of materials. In one embodiment,for example, a biologic layer is formed with positively-chargedsynthetic spheres embedded or implanted throughout the biologic layer.It is also appreciated that any support structures or other component ofan adjunct material layer can have an electrical charge.

The electrical (e.g., positively) charge can attract additional cellsand enhance healing in vivo. For example positively charged adjunctmaterials can help cells grow onto the material (i.e., increase cellmobility) and can attract additional cells to the wound site itself. Toillustrate this, FIG. 33A depicts a standard cell dispersion 16000 of ahealing area 16020 that contains uncharged polymer spheres 16040, forexample as part of a polymer scaffold, and a plurality of cells 16060.It can be seen that some of the cells 16060 adhere to the unchargedpolymer spheres 16040, however there is no appreciable accumulation ofcells 16060 near the uncharged polymer spheres 16040. By contrast, FIG.33B illustrates a cell dispersion 1600′ of healing area 1602′ havingpositively charged polymer spheres 1604′ and cells 1606′. As can be seencells 1606′ are attracted into the area of the positively chargedpolymer sphere 1604′ due to the positive charge of the polymer spheres1604′. Because the spheres 1604′ attract additional cells 1606′ to thehealing area 1602′, the healing area 1602′ (i.e., a wound site) canexperience enhanced healing and cellular ingrowth.

By way of example only, FIG. 34 shows a mechanism by which an adjunctmaterial (“implant”) 17020 having positively charged particles canenhance healing at a wound site area 17000. As shown, various cells,including T-cells 17040, macrophages 17060, and neutrophils 17080, arepresent in the wound site area 17000 as these cells are typically foundflowing through the circulatory system, such as in a blood vessel 17100.Blood vessels are typically lined with endothelial cells 17120 thatallow blood components such as erythrocytes (not shown), fibroblasts(not shown), platelets 17140, platelet-derived growth factor (“PDGF”)17200, T-cells 17040, macrophages 17060, and neutrophils 17080 to passfrom an interior 17160 of the blood vessel 17100 through the endothelialcell lining 17120 and into the wound area 17000. A person skilled in theart will understand that blood and blood components are negativelycharged. Thus, because the implant 17020 has positively chargedparticles, inflammatory cells and blood components responsible forhealing the wound site (which, as mentioned, can be negatively charged),including platelets 17140, PDGF 17200, T-cells 17040, macrophages 17060,and neutrophils 17080 are attracted to the implant surface 17020 andthus the wound site 17000 thereby enhancing healing relative to a systemthat does not have increased cell attraction. Additionally, thepositively charged implant 17020 can activate tissue macrophages 17060.When activated, macrophages 17060 release growth factors and activecytokines into the wound, providing a stimulus for cell proliferationand collagen matrix deposition, thus further enhancing healing.

Materials that work using the positive charge mechanism described abovecan include a polysaccharide backbone (matrix) with attached functionalgroups, for example cellulose or dextrose gels. Additionally, a personskilled in the art will appreciate that the key to enabling desirablewound healing lies in the functional groups, which can includediethylaminoethyl and quarternay amine groups.

At least portions of adjunct material, or any other extra cellularmatrix (ECM) materials, can have a charge induced or otherwise producedthereon. To produce an electrical (e.g., positive) charge on absorbablepolymers, any suitable method and material can be used. In someembodiments, a permanent positive charge can be induced or otherwiseformed on at least a portion of an adjunct material, preferably at leaston an outer surface of the material. In some embodiments, for example, apositively charged initiator molecule can be used to induce a ringopening polymerization of cyclic monomers. Any known cyclic monomer canbe used during synthesis of absorbable polymers and copolymers, such asglycolide, lactide, caprolactone, p-dioxanone, and combinations thereof.

The initiator molecules can be any positively charged molecule thatinitiates the ring opening polymerization of the cyclic monomer(s).Examples of initiator molecules that can be used to create permanentpositive charge on absorbable polymers include2,3-dihydroxyporpyldimethylalkylammonium chloride such as is representedby formula (I), choline such as is represented by formula (II), andcholine functionalized dimethylolpropionic acid such as is representedby formula (III):

where R is H or an alkyl chain,

where X is Cl, Br, or I, and

where X is Cl, Br, or I.

Use of these initiators during synthesis of various absorbable polymersand copolymers can result in absorbable polymers/copolymers with apositive charge either at the end of the polymer chains or as a pendantgroup attached to the polymer backbone. A positive charge produced usingthese initiators can be substantially permanent. Using these initiatorsand/or process, a positive charge can be created on any of the syntheticpolymers or copolymers described herein, such as such as a polydioxanonefilm sold under the trademark PDS® or with a Polyglycerol sebacate (PGS)film or other biodegradable films formed from PGA (Polyglycolic acid,marketed under the trade mark Vicryl), PCL (Polycaprolactone), PLA orPLLA (Polylactic acid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone25, sold under the trademark Monocryl), PANACRYL (Ethicon, Inc.,Somerville, N.J.), Polyglactin910, Poly glyconate, PGA/TMC(polyglycolide-trimethylene carbonate sold under the trademark Biosyn),polyhydroxybutyrate (PHB), poly(vinylpyrrolidone) (PVP), poly(vinylalcohol) (PVA), or a blend of copolymerization of the PGA, PCL, PLA, PDSmonomers. For example, exemplary copolymers include copolymers ofPGA/PCL and/or PLLA/PCL, such as various polymers having PGA/PCL ratiosin the range of about 25:75 to 90:10, and/or PLLC/PCL in the range ofabout 70:30. Additionally, in some embodiments preparation of foams vialyophilization of solutions of these polymers and/or copolymers canresult in a porus matrix having a positive charge throughout the matrix.

Hybrid Adjunct Material

The retention members provided for herein, or otherwise known to thoseskilled in the art, can be used in conjunction with a variety of adjunctmaterials. While in some instances the adjunct materials can be either asynthetic material or a biologic material, in some exemplary embodimentsthe adjunct material can include both synthetic material(s) and biologicmaterial(s), referred to herein as a hybrid adjunct material. Theresulting combination can advantageously have both permeable andnon-permeable elements, and allows for the beneficial features of bothtypes of adjunct materials to be incorporated into a single adjunctmaterial. For example, synthetic material can provide structure andsupport for biologic material, and can add strength and shear resistanceto fibrous biologic material, while still being configured to allow thebiologic material to have direct access to a surgical site so thebiologic material can provide improved healing and tissue growth at thestapled location. Depending on the type of material that is used, eitheror both synthetic and biologic material can help seal holes formed bystaples as they are implanted into tissue, blood vessels, and variousother objects or body parts. Further, either or both of the syntheticand biologic materials can be configured to help reduce inflammation,promote cell growth, and otherwise improve healing.

A hybrid adjunct material can be selectively attached to either or bothjaws of an end effector. As shown in FIGS. 35A and 35B, a hybrid adjunctmaterial 3400, 3400′ is attached to both lower and upper jaws 31052,31054 of an end effector 31050. The hybrid adjunct material 3400, 3400′of the illustrated embodiment includes a synthetic material, layer, ormatrix 3402, 3402′ in the form of a polymer mesh, and a biologicmaterial, layer, or matrix 3404, 3404′ in the form of a bioabsorbablemembrane. The terms material, layer, and matrix are often usedinterchangeably herein, and to the extent any of these terms are used,the terms are not so limiting as to require a particular shape,thickness, or configuration. A person skilled in the art will recognizea variety of configurations that the synthetic and biologic materialscan have that allow them to be used in conjunction with an end effectorwithout departing from the spirit of the present disclosure. Asdescribed herein, the synthetic and biologic layers 3402, 3402′ and3404, 3404′ can be coupled to the lower and upper jaws 31052, 31054using a variety of techniques, but in the illustrated embodiment a pairof brackets 3406 is used to maintain a location of the hybrid adjunctmaterial 3400 with respect to the cartridge assembly or lower jaw 31052.Likewise, a pair of brackets 3406′ is used to maintain a location of thehybrid adjunct material 3400′ with respect to the upper jaw 31054.

The lower jaw 31052 and associated hybrid adjunct material 3400 areillustrated in FIG. 35A. Similar to some of the embodiments describedherein, the lower jaw 31052 can have a staple cartridge 31100 disposedtherein. The staple cartridge 31100 can include staples for deploymentat the surgical site, and as shown, can include support struts 31103.The support struts 31103 can help stabilize the cartridge 31100 within asupport channel 31056 of the lower jaw 31052, and can also be engaged bythe brackets 3406 to help temporarily secure the hybrid adjunct material3400 to the lower jaw 31052.

The biologic layer 3404 can have many different configurations in termsof its size, shape, and the materials of which it is comprised, but inthe illustrated embodiment the biologic layer 3404 is substantiallyplanar and rectangular, and includes a bioabsorbable membrane. Thebiologic layer 3404 can be in the form of an extracellular matrix,and/or it can include patient-derived materials such as plateletenriched plasma, diced tissue fragments, fibrin, and stem cells. Othertypes of biologic materials that can be incorporated into the biologiclayer 3404 are provided earlier in this disclosure. As shown in FIGS.35A and 35B, a bottom surface 3404 b of the biologic layer 3404 isfacially opposed to a top surface 31100 a of the staple cartridge 31100and the two surfaces 3404 b, 31100 a are in contact with each other.

The synthetic layer 3402 can likewise have many different configurationsin terms of its size, shape, and the materials of which it is comprised.In the illustrated embodiment the synthetic layer 3402 is substantiallyplaner and rectangular and includes a plurality of openings 3408 formedtherein to provide a lattice structure or mesh. This open configurationallows components of the biologic layer 3404 to pass through thesynthetic layer 3402 and provide desired healing to tissue at thesurgical site, while still providing a support structure for thebiologic layer 3404. If the synthetic layer 3402 was not permeable andcontained no openings, it could act as a barrier between the tissue andthe biologic layer 3404. Thus, in instances in which there are noopenings, typically the synthetic layer 3402 is permeable. Any number ofmaterials can be used to form the synthetic layer 3402, including thosedescribed above, but in some embodiments a polymer is used. Further,healing agents and/or biologic materials can be incorporated into thesynthetic layer 3402, for instance by painting a layer of the agentsand/or biologic materials on a top surface 3402 a of the synthetic layer3402. As shown in FIGS. 35A and 35B, a bottom surface 3402 b of thesynthetic layer 3402 is facially opposed to a top surface 3404 a of thebiologic layer 3404 and the two surfaces 3402 b, 3404 a are in contactwith each other.

The one or more brackets 3406 can be used to maintain the location ofthe biologic and synthetic layers 3404, 3402 with respect to the staplecartridge 31100 and lower jaw 31052. In the illustrated embodiment, twoopposed brackets 3406 are configured to engage a bottom surface 31103 bof the strut 31103 and the top surface 3402 a of the synthetic layer3402 to maintain the location of the layers 3404, 3402. The brackets3406 can have any number of shapes, sizes, and configurations, but inthe illustrated embodiment of FIGS. 35A and 35B, a channel 3410 forengaging the top surface 3402 a of the synthetic layer 3402 extends thelength of a top portion 3406 a of the bracket 3406, and a plurality ofengagement tabs 3412 for engaging the bottom surface 31103 b of thestruts 31103 extend from the channel 3410. As also shown in FIG. 35B,the hybrid adjunct material 3400′ that includes the biologic layer 3404′and the synthetic layer 3402′ can also be associated with an anvil orupper jaw 31054 of the end effector 31050, for instance by using opposedbrackets 3406′. As shown, top channels 3410′ of the brackets 3406′engage a surface of a cover plate 31062 of the upper jaw 31054, and thebottom tabs 3412′ engage a bottom surface 3402 b′ of the synthetic layer3402′. The synthetic and biologic layers 3402′, 3404′ associated withthe upper jaw 31054 can have the same size, shape, and composition asthe synthetic and biologic layers 3402, 3404 associated with the lowerjaw 31052, or the sizes, shapes, and compositions can be different.Additional details about associating a hybrid adjunct material with ananvil are provided further below.

FIG. 36 provides another configuration of hybrid adjunct materials 3500,3500′ associated with each of the lower and upper jaws 31052, 31054. Asshown, a biologic layer 3504 associated with the lower jaw 31052 isdisposed between two synthetic layers 3502, 3503, and a biologic layer3504′ associated with the upper jaw 31054 is disposed between twosynthetic layers 3502′, 3503′. The synthetic layers 3502, 3502′ can bepermeable so as to allow biologic materials from the respective biologiclayers 3504, 3504′ to pass through the synthetic layer 3502, 3502′ andinteract with surrounding tissue upon deployment. The synthetic layer3503, 3503′ can also be permeable. Optionally, either or both of thesynthetic layers 3502, 3502′ and 3503, 3503′ can have one or moreopenings formed therein to allow biologic material to pass therethrough.In one exemplary embodiment, the synthetic layers 3502, 3502′ and 3503,3503′ are an absorbable alginate membrane and the biologic layers 3504,3504′ include platelet rich plasma (PRP). The synthetic and biologicmaterials associated with the lower and upper jaws 31052, 31054 can be,but do not have to be, the same shape, size, and/or composition.

Opposed brackets 3506 can be used to maintain the location of thesynthetic and biologic layers 3502, 3503, 3504 with respect to the lowerjaw 31052, and opposed brackets 3506′ can be used to maintain thelocation of the synthetic and biologic layers 3502′, 3503′, 3504′ withrespect to the upper jaw 31054. While any configuration of bracket canbe used, in the illustrated embodiment the brackets 3506, 3506′ includetop and bottom channels 3510, 3512 and 3510′, 3512′ that extend a lengthof the brackets 3506, 3506′ and an end wall 3514, 3514′ that connectsthe two channels 3510, 3512 and 3510′, 3512′. As shown, the bottomchannel 3512 engages the bottom surface 31103 b of the struts 31103 andthe top channel 3510 engages a top surface 3502 a of the synthetic layer3502, while the bottom channel 3512′ engages a bottom surface 3502 b ofthe synthetic layer 3502 and the top channel 3510′ engages a surface ofthe cover plate 31062 of the upper jaw 31054.

Optionally, one or more ports 3520,3520′ can be formed in the hybridadjunct material 3500, 3500′ and/or the brackets 3506, 3506′ to allowmaterials, such as patient-derived materials, including fluids, to beinjected into the hybrid adjunct material 3500, 3500′. The ports 3520,3520′ can be non-permeable and self-sealing. In the illustratedembodiment, the ports 3520, 3520′ extend through the brackets 3506,3506′ and into the biologic layers 3504, 3504′, however in otherembodiments, such as those in FIGS. 35A and 35B in which the brackets3406, 3406′ do not cover a length-wise edge of the hybrid adjunctmaterial 3400, 3400′, the ports can be formed in one or both of thesynthetic and biologic layers 3502, 3502′ and 3504, 3504′ without beingformed in the brackets.

In other embodiments of a hybrid adjunct material, a synthetic layer canbe coupled to a jaw of the end effector and can include one or moremating features for receiving and coupling to a biologic layer. Forexample, FIG. 37 illustrates a lower jaw 51052′ having a hybrid adjunctmaterial 5600 associated therewith. A synthetic material, layer, ormatrix 5602 of the hybrid adjunct material 5600 can be coupled to thejaw 51052′ using retention members 51202′ extending across proximal anddistal ends 51052 p′, 51052 d′ thereof. Further, the synthetic matrix5602 can include one or more protrusions, as shown springs 5616, whichare adapted to engage a biologic material, layer, or matrix 5604 to matethe biologic matrix 5604 to the synthetic matrix 5602, therebysubstantially maintaining a location of the biologic matrix 5604 withrespect to the synthetic matrix 5602 and the lower jaw 51052′. In theillustrated embodiment, the springs 5616 form a skeletal structurearound which the biologic matrix 5604 can be formed. For example, whenthe biologic matrix 5604 is formed from collagen, which as discussedelsewhere in this disclosure can be melted into its aqueous state andthen reformed into a hardened state, the synthetic matrix can be dippedin the collagen when the collagen is in its aqueous state. As thecollagen reforms or hardens, it can form around the skeletal structuredefined by the configuration of the springs 5616, thereby integratingthe biologic matrix with the synthetic matrix during refinement. Theresulting hybrid adjunct material can be a macro-composite adjunct thatbenefits from the strength and tear resistance of the internal syntheticframe and the simple parameter attachment features provided by thesprings 5616, e.g., the shape and material of the springs, while stillproviding for the benefits of having biologic material at theimplantation site. A person skilled in the art will recognize a varietyof other protrusions that can extend from a top surface 5602 a of thesynthetic matrix 5602 in any number of configurations to provide aninternal skeletal structure for forming a hybrid adjunct material.

Synthetic materials or layers can have a variety of other configurationsthat are conducive to both providing a support structure for thebiologic materials or layers while permitting the biologic materials topass therethrough so that they can interact with tissue engaged by thestaple. Various configurations are illustrated herein. As shown in FIG.38, a synthetic material, layer, or matrix 5702 is coupled to a lowerjaw 51052″ by retention members 51202″, which as shown are sutures,disposed at proximal and distal ends 51052 p″, 51052 d″ thereof. Thesynthetic layer 5702 can include a large, central opening 5708 formedtherein to permit biologic materials disposed above the synthetic layer5702 to interact with the staples disposed in a staple cartridge 51100″below, as well as the tissue in which the staples are injected.Accordingly, the synthetic layer 5702 can serve as a frame for thehybrid adjunct material 5700, configured to only be disposed around aperimeter of a biologic layer disposed on top of the synthetic layer5702. Shoulders 5718 formed on outer edges 5702 e of the synthetic layer5702 can provide structure that at least one of a biologic layer and acoupling mechanism like a bracket can engage to attach the biologiclayer to the synthetic layer 5702, and thus the lower jaw 51052″.

The lower jaw 51052″ of FIG. 39 also provides for a synthetic material,layer, or matrix 5702′ that permits biologic materials to passtherethrough. As shown, the synthetic layer 5702′ is coupled to thelower jaw 51052″ by retention members 51202″, e.g., sutures, disposed atproximal and distal ends 51052 p″, 51052 d″ thereof. A plurality ofopenings 5708′ can be formed therein such that the synthetic layer 5702′has a matrix or lattice structure, with the bars forming the latticeextending diagonally to a length of the layer 5702′ and substantiallyperpendicular with respect to each other. Similar to openings in othersynthetic materials, the openings 5708′ can permit biologic materials topass therethrough. The synthetic layer 5702′ can include shoulders ortabs 5718′ formed on its edges 5702 e′. As a result, a biologic materialsuch as the material, layer, or matrix 5704′ illustrated in FIG. 39 canhave channels 5720′ formed therein that are configured to engage theshoulders 5718′, as described in further detail below with respect to arelated embodiment illustrated in FIGS. 40A-E.

The biologic layer can be coupled to the synthetic layer using a numberof techniques, such as the brackets discussed above. In anotherexemplary embodiment one of the synthetic and biologic layers can beconfigured to form a snap-fit with the other layer. As shown in FIG.40A, a synthetic material layer 6802 is disposed over a staple cartridge61100′″ and coupled to a lower jaw 61052′″ of an end effector 61050′″ ofan attachment portion 61016′″ by retention members 61202′″ disposed atproximal and distal ends 61052 p′″, 61052 d′″ thereof. The syntheticlayer 6802 can be generally permeable, and can include shoulders 6818for receiving a biologic material, layer, or matrix 6804 (FIG. 40B) toform a hybrid adjunct material 6800. Further, as shown in FIG. 40B, thesynthetic layer 6802 can include a groove 6822 formed at a proximal end6802 p thereof for receiving a knife that passes through the endeffector 61050′″. The groove 6822 enables the knife to cut the syntheticlayer 6802 to release the synthetic and biologic layers 6802, 6804 fromthe end effector 61050′″ and allows the layers 6802, 6804 to be securedat the treatment location by staples of the staple cartridge 61100′″.

The biologic layer 6804 can include opposed channels 6820 configured toform a snap-fit with the synthetic layer 6802. As shown in FIG. 40B, thechannels 6820 extend along a substantial length of the biologic layer6804. A proximal end 6804 p of the biologic layer 6804 can include aportion that is sized to be complementary with a proximal end 6802 p ofthe synthetic layer 6802. Accordingly, as shown, the proximal end 6804 pof the biologic layer 6804 can have a smaller width than a distal end6804 d thereof, just as the proximal end 6802 p of the synthetic layer6802 also has a smaller width than a distal end 6802 d thereof.

As shown in FIG. 40C, a first lengthwise outer edge 6802 e 1 of thesynthetic layer 6802 can be disposed in a first channel 6820 a of thebiologic layer 6804. The biologic layer 6804, which can be pliable, canbe flexed to allow a second lengthwise outer edge 6802 e 2 of thesynthetic layer 6802 to be disposed in a second channel 6820 b of thebiologic layer 6804. The resulting configuration is illustrated in FIGS.40D and 40E. The fit between the biologic layer 6804 and the syntheticlayer 6802 can generally be of the nature that, once coupled along bothlengthwise edges, leaves the biologic layer 6804 generally free ofstress and tension. Further, the synthetic layer 6802 can providesupport for the biologic layer 6804 to prevent it from easily fallingapart. As discussed in greater detail below, as staples are ejected by aknife passing through the end effector 61050′″, the hybrid adjunctmaterial 6800 is maintained at the surgical site by the staple, andbecomes disassociated with the end effector 61050′″ when the knife cutsthe retention members 61202′″. Even though a matrix or other openingsare not overtly formed in the illustrated synthetic layer 6802, thesynthetic layer 6802 can be permeable, thereby allowing materials fromthe biologic layer 6804 to pass therethrough before, during, and afterstaple delivery. In other embodiments the synthetic layer 6802 caninclude a matrix, lattice, or other structure containing one or moreopenings as described above to permit passage of biologic materials fromthe biologic layer to tissue being stapled.

As illustrated in FIGS. 35B and 36, a hybrid adjunct material 3400′,3500′ can be associated with an anvil or upper jaw 31054 in addition toor in lieu of associating the hybrid adjunct material 3400, 3500 withthe cartridge assembly or lower jaw 31052 of the end effector 1050. Inthose earlier described embodiments, brackets 3406, 3506 and 3406′,3506′ are used to maintain a location of the hybrid adjunct materials3400, 3500 and 3400′, 3500′ with respect to the lower and upper jaws31052 and 31054. FIGS. 41A and 41B illustrate another embodiment inwhich a hybrid adjunct material 900 is associated with an anvil or upperjaw 1054″″ of an end effector 1050″″ of an attachment portion 1016″″. Asshown, a synthetic material, layer, or matrix 902 is coupled to theanvil 1054″″ using retention members 1202″″ on proximal and distal ends1054 p″″, 1054 d″″ of the anvil 1054″″. A biologic material, layer, ormatrix 904 is coupled to the anvil 1054″″ in a manner similar to themanner described above with respect to the lower jaw 1052′ of FIG. 37.Accordingly, one or more protrusions (not shown) can extend from thesynthetic layer 902 and into the biologic layer 904 such that the twolayers 902, 904 are coupled together.

FIGS. 42A-42C provide for an embodiment of an adjunct material 2000associated with an anvil or upper jaw 2054 that is completely biologic.Such a configuration can still be considered a hybrid adjunct materialto the extent it incorporates multiple biologic materials. As shown, thebiologic layer 2004 includes a collagen matrix configured to couple tothe anvil 2054 of an end effector 2050. The formation of the biologiclayer 2004 can be achieved by purifying and refining collagen. Thecollagen purification and refinement process can suspend the collagen inan aqueous state. While in this state, fats and other impurities of thecollagen can be skimmed off. The aqueous collagen can then be formedinto a desired biologic layer shape. For example, the aqueous collagencan be poured into a mold having inverse pockets formed therein that arecomplementary to the shape of an interior surface of the anvil 2054.Temperature and surface conditions of the mold can be controlled orotherwise tuned by the user to control parameters of the resultinglayer, such as the density. In some embodiments an approximately uniformdensity can be achieved across the layer, while in other embodiments thetemperature and surface conditions can be tuned such that the density ofthe biologic layer 2004 is not uniform across its body. For example,density variants can be formed around inverse pocket shapes formed inthe biologic layer 2004. As a result, once the collagen solidifies, thebiologic layer 2004 can be keyed into the anvil 2054 of the end effector2050. In some embodiments, a protrusion (not shown) can be formed thatis complementary to a longitudinal slot 2066 formed in the anvil 2054such that protrusion on the biologic layer 2004 can help to maintain thelocation of the biologic layer 2044 with respect to the anvil 2054before and during staple ejection.

In the illustrated embodiment, the biologic layer 2004 is made frombiologic material that has adhesive or semi-adhesive properties. By wayof non-limiting example, the biologic layer 2004 can be formed by usinga thin film of polyglycolic acid (PGA)/poly (ε-caprolactone (PCL), whichin a thin film acts as a semi-adhesive. In one exemplary embodiment thePGA/PCL balance is approximately 65/35, although other combinations canbe used. A film having approximately this configuration can be such thatafter the staples are ejected, the remaining collagen would be minimal.More particularly, when compressed against tissue 3000 during clampingthe main collagen body of the biologic layer 2004 and the pockets can becrushed, thus, as shown in FIG. 42B, creating a layer that would easilybe penetrated by a staple 2101″ but would prevent tissue from enteringthe staple forming area or staple pocket 3002. Still further, after thestaple 2101″ is fully formed, the collagen matrix of the biologic layer2004 can be configured to swell and fill gaps, as shown in FIG. 42C. Forexample, liquids such as hydrogel, oxidized regenerated cellulose (ORC),or alginate can be included as part of the collagen matrix, which helpto seal around the legs of the staple 2101″ and minimize damage duringstapling. As a result, both during and after staple firing, thepotential for damage to the vessel, and the potential for bleeding atthe surgical site, are reduced.

FIGS. 43A-D illustrate another embodiment of an adjunct material 2200′configured to couple to an anvil or upper jaw 2054′ of an end effector2050′. As shown the adjunct material 2200′ includes two biologiclayers—a first layer 2204′ that includes ORC gel and a second layer2205′ that is formed, at least in part, from omentum and serves as ascaffold or support for the first layer 2204′. The first layer 2204′ cancreate a viscous layer capable of damming up bleeding, thereby allowingthe body to more readily clot. In alternative embodiments, as describedabove, a layer of ORC gel can be used in conjunction with a thin filmlike PGA/PCL. The film of PGA/PCL can help prevent the ORC gel fromactivating too quickly when in contact with body fluids, and can helpprovide shear, tear, and/or axial strength.

The second layer 2205′ can also provide shear, tear, and axial strengthfor the adjunct material 2200′. Omentum is a biologically derivedadjunct, and as shown can be formed into a scaffold to help support theORC gel of the first layer 2204′. Further, omentum is generallycompatible with tissue, is capable of mitigating bleeding, and cangenerally assist in the tissue healing process. The first layer 2204′can be coupled to the second layer 2205′ using any techniques known tothose skilled in the art and/or described herein. For example, they canbe mechanically attached similar to the embodiment of FIG. 37.Alternatively, an adhesive or semi-adhesive collagen layer can bedisposed therebetween to serve as a coupling agent. Likewise, the secondlayer 2205′ can be coupled to the anvil 2054′ using any techniques knownto those skilled in the art and/or described herein. In the illustratedembodiment, an adhesive material such as collagen (not shown) can beapplied to either or both of the second layer 2205′ and the anvil 2054′to maintain the location of the second layer 2205′, and thus the firstlayer 2204′ coupled thereto, with respect to the anvil 2054′. In someembodiments, a third layer (not shown), which like the second layer2205′ can include omentum, can be provided and the first layer 2204′ canbe sandwiched between the two layers that include omentum. For example,the third layer can be is disposed more proximate to a staple cartridgedisposed in a cartridge assembly or lower jaw than the second layer2205′, and thus can help shield the ORC gel of the first layer 2204′from premature activation by tissue disposed between the jaws of the endeffector 2050′.

As a staple 2101′ is ejected from the cartridge 2100′ and into tissue3000′, the first layer 2204′ helps prevent tissue from entering thestaple forming area or staple pocket 3002′, as shown in FIG. 43C. Thetissue 3000′ at the surgical site can activate the ORC gel of the firstlayer 2204′. Accordingly, the ORC gel of the first layer 2204′ can beginto melt as it becomes wet. As the ORC melts, it can form a seal aroundthe legs of the staple 2101′. As shown in FIG. 43D, a thickness of thefirst layer 2204′ can be significantly reduced due to the melting, whilethe second layer 2205′ can work in conjunction with the melting ORC toseal holes and gaps around the staple 2101′.

FIGS. 44A-44C provide additional, non-limiting techniques by which ahybrid adjunct material can be formed using both biologic material(s)and synthetic material(s). For example, as shown in FIG. 44A, a hybridadjunct material 2300′″ having a snap-fit configuration can be formed inwhich the synthetic material, layer, or matrix 2302′″ is configured tohave features for receiving the biologic material, layer, or matrix2304′″. As shown, the synthetic layer 2302′″ includes opposed channels2324′ formed in outer edges 2302 e′″ of the layer 2302′″, and thebiologic layer 2304′″ can be pliable such that it can be snap-fit intothe synthetic layer 2302′″. In an alternative embodiment of a hybridadjunct material 2300′, which is illustrated in FIG. 44B, a syntheticmaterial, layer, or matrix 2302′ can be configured to have a biologiclayer 2304′ placed on top of it and then the two layers 2302′, 2304′ canbe laminated together. A person skilled in the art will understandvarious techniques that can be performed to laminate the two layers2302′, 2304′ together. In a further alternative embodiment of a hybridadjunct material 2300″, a synthetic material, layer, or matrix 2302″ canhave biologic material 2304″ imbibed into the layer 2302″, as shown inFIG. 44C. Other techniques capable of being used to combine syntheticmaterial(s) and biologic material(s) to form a hybrid adjunct materialcan also be used without departing from the spirit of the presentdisclosure.

A hybrid adjunct material that results from combining syntheticmaterial(s) with biologic materials(s) as provided for herein can beassociated with any and all of a cartridge assembly or lower jaw, astaple cartridge, and an anvil or upper jaw of an end effector usingtechniques known to those skilled in the art or otherwise provided forherein. For example, with respect to the hybrid adjunct materials 2300,2300′ of FIGS. 44A and 44B, the synthetic matrices 2302, 2302′ can bepre-attached to any of a lower jaw, a staple cartridge, and an upper jawand then the biologic layer 2304, 2304′ can be attached theretoimmediately prior to delivery. By way of further non-limiting example,such as for the embodiment of FIG. 44C, the hybrid adjunct material2300″, which includes both synthetic and biologic materials in the samelayer, can be attached to the any of a lower jaw, a staple cartridge,and an upper jaw just prior to delivery of staples to a surgical site.

The components of hybrid adjunct materials can be associated with eachother at any desired time, however, it can be preferable to add thebiologic material(s) on site if the materials has a limited shelf-life,which many biologic materials do, particularly if they are not dry.Accordingly, as shown in FIGS. 45A and 45B, an attachment portion 2016″having an end effector 2050″ with a synthetic material, layer, or matrix2402″ associated therewith can be packaged in a first container 4000,while a biologic material, layer, or matrix 2404″ can be packaged in asecond container 4002, separate from a first container 4000. As shown,the synthetic layer 2402″ is pre-attached to the end effector 2050″ byretention members 2202″. Storing the biologic material 2404″ in aseparate, closed environment can be conducive to preserving itsshelf-life. For example, the biologic material 2404″ can be refrigeratedprior to associating it with the synthetic material 2402″ for subsequentdeployment. Alternatively, the biologic material can be completelydried, which can also improve its shelf-life. In other embodiments, thesynthetic material, layer, or matrix can be initially detached from anend effector, and can be packaged with or separate from either of theend effector or the biologic material. Prior to delivery of thesynthetic and biologic materials to the surgical site, the two materialscan be combined to form a hybrid adjunct material and can then beattached to the end effector for subsequent use at the surgical site. Aperson skilled in the art will understand other techniques that can beused to package the tool and the components of the hybrid adjunctmaterial to preserve the shelf-life of any biologic materials withoutdeparting from the spirit of the present disclosure.

Hybrid Adjunct Materials with Compressible Elastic Members

The compressible elastic members described herein, or otherwise known tothose skilled in the art, can be used in conjunction with a variety ofadjunct materials. While in some instances adjunct materials can beeither a synthetic material or a biologic material, in variousembodiments the adjunct material includes both synthetic material(s) andbiologic material(s) (i.e., it is a hybrid adjunct material). Theresulting combination can advantageously exhibit beneficial featuresfrom both types of materials in a single hybrid material. For example, ahybrid adjunct material can be designed to combine benefits of biologicmaterial (such as improved healing and tissue growth at a surgical site)with desirable mechanical properties of synthetic material (such asspringiness or elasticity). In various embodiments, a synthetic materialcan also provide structure and support for a biologic material (e.g.,add strength and/or shear resistance to fibrous biologic material),while still allowing the biologic material to contact a surgical siteand support and/or promote healing. Further, hybrid adjunct materialscan be configured to help reduce inflammation, promote cell growth,and/or otherwise improve healing. The hybrid adjunct material can bebioimplantable and bioabsorbable.

FIG. 46 is a perspective view of an exemplary staple cartridge assemblythat includes a cartridge body and a hybrid adjunct material. Here, thecartridge body and staples (not shown) are encased by lower jaw 71052 ofan end effector of a surgical instrument (see, e.g., FIGS. 1 and 10).The cartridge body has a plurality of staple cavities configured to seatstaples therein (see, e.g., FIGS. 4 and 10). The hybrid adjunct material7600 is releasably retained on the cartridge body and the lower jaw71052 and configured to be delivered to tissue by deployment of thestaples from the cartridge body (as will be discussed in connection withthe example of FIGS. 51-53 below). The material 7600 includes a biologictissue membrane or matrix 7604 (shown as being partially cutaway toillustrate the compressible elastic members or spring members 7616), asynthetic substrate layer or matrix 7602, and at least one compressibleelastic member or spring member 7616 configured to compress when acompressive force is applied thereto, and to provide a spring back forcewhen the compressive force is removed. Because the compressible elasticmember or spring member 7616 (also referred to as a “skeleton”) isinternal to the biologic tissue membrane or matrix 7604, irritation andinflammation from synthetic material can be minimized while the biologictissue membrane or matrix 7604 is still provided with a compliantreinforcement.

In the illustrated embodiment of FIG. 46 (and similarly in FIGS. 47-49and 51-53), the biologic tissue membrane 7604 is on a tissue contactingside of the hybrid adjunct material 7600 while the synthetic substratelayer 7602 is on the side of the material 7600 facing the cartridgebody. A person skilled in the art will also appreciate that the relativepositions of layers 7602 and 7604 can be reversed. A person skilled inthe art will also appreciate that while the cartridge assembly of FIG.46 includes a hybrid adjunct material, an adjunct material that includesone or more spring members and only one of a biologic layer and asynthetic layer may alternatively be used. In various embodiments,hybrid adjunct materials can include a number (and arrangement) ofcompressible spring members selected to achieve a desired mechanicalproperty. For example, the number of spring members may be matched tothe number (and location) of staples, or the number of spring membersmay be the number required to cover the biologic tissue membrane orsynthetic substrate layer, or a predetermined region thereof (e.g., afunction of the size of the spring member and membrane or layer).

Further, in the illustrated embodiment of FIG. 46 (and similarly inFIGS. 47-49 and 51-53), the hybrid adjunct material is assembled to anend effector for context and ease of description. A person skilled inthe art will appreciate that that hybrid adjunct materials can beprovided in alternatively configured assemblies with an end effector,and can be provided separately from an end effector (or other componentof a surgical stapler) and subsequently affixed to a portion of the endeffector.

The hybrid adjunct material can be coupled to a jaw of the end effector(in this example through the synthetic substrate layer) and can includeone or more mating features for receiving and coupling to a biologiclayer. For example, FIG. 46 illustrates a synthetic material, layer, ormatrix 7602 of the hybrid adjunct material 7600 coupled to the jaw 71052using retention members 71202 extending across proximal and distal ends71052 p, 71052 d thereof. Further, the synthetic matrix 7602 can includeone or more protrusions, shown here as springs 7616, which areconfigured to engage a biologic material, layer, or matrix 7604 toassist in mating the biologic matrix 7604 to the synthetic matrix 7602,thereby substantially maintaining a location of the biologic matrix 7604with respect to the synthetic matrix 7602.

In this embodiment, the compressible elastic members or spring members7616 form a skeletal structure around which the biologic matrix 7604 isformed. For example, when the biologic matrix 7604 is formed fromcollagen, which as discussed elsewhere in this disclosure can be meltedinto a liquid state and then reformed into a hardened state, thesynthetic matrix can be dipped in liquid collagen. As the collagenreforms or hardens, it can form around the skeletal structure defined bythe configuration of the springs 7616, thereby integrating the biologicmatrix with the synthetic matrix. The resulting hybrid adjunct materialcan be a macro-composite adjunct that benefits from the strength andtear resistance of the internal synthetic frame and the simple parameterattachment features provided by the springs 7616, e.g., the shape andmaterial of the springs, while still providing for the benefits ofhaving biologic material. A person skilled in the art will recognize avariety of other protrusions that can extend from a top surface 7602 aof the synthetic matrix 7602, to provide an internal skeletal structurefor forming a hybrid adjunct material.

A person skilled in the art will appreciate that compressible elasticmembers having a variety of shapes, sizes, and configurations, andmaterials, can be used with the adjunct material disclosed herein. Inone embodiment, shown in FIG. 46, the adjunct material includes springmembers 7616 in the form of elongate members that extend along at leastone dimension of the adjunct material. For example, in the illustratedembodiment, spring members 7616 can be elongate members that have raisedsegments 7618 separated by non-raised segments 7617. In one example, theelongate members 7616 can form a sinusoidal or wave-like pattern.Although FIG. 46 illustrates elongate members 7616 extending across awidth (W) dimension, a person skilled in the act will recognize that theelongate members can alternatively, or in addition, extend along alength (L) dimension or another dimension (i.e., in FIG. 46, a dimensionthat is not parallel or perpendicular to the length dimension or widthdimension). A person skilled in the art will also appreciate that springmembers can take a variety of alternative forms. Virtually any shape canbe utilized as long as it is able to provide a spring back force when acompressive force is removed. Further, the spring member can be disposedin or on either the biologic and/or synthetic layer, or disposed betweenlayers.

FIGS. 47-50C illustrate additional exemplary attachments of biologicaltissue reinforcement membranes to cartridge bodies, and exemplarycompressible elastic members. In FIG. 47, the hybrid adjunct material82000 includes spherical, or orbit-like, elastic members 82016 disposedbetween a synthetic layer 82002 and biologic matrix 82004, and embeddedwithin the biologic matrix 82004. In FIG. 48, the hybrid adjunctmaterial 82100 includes radially projecting, atom-like, or jack-likeelastic members 82116 embedded within the biologic matrix 82104. In FIG.49, the hybrid adjunct material 82200 includes hemispherical, or domed,elastic members 82216 embedded within the biologic matrix 82204.

FIG. 50A is an exploded view of a variation of the compressible elasticmember illustrated in FIG. 47. The spherical, or orbit-like, elasticmember 82320 includes a plurality of circular, or elliptical components82330 defining a three dimensional spherical, or orbit-like shape. Aperson skilled in the art will appreciate that such elastic members caninclude two or more circular or elliptical components, which can bearranged in a regular or irregular pattern. A person skilled in the artwill also appreciate that the mechanical properties of such elasticmembers can be modulated, for example, by appropriate selection of thematerial, size, shape, position, and/or number of circular or ellipticalcomponents. These and other elastic members can include one or moresurface features, or features of the three dimensional shape of theelastic member itself, configured to fix the membrane to the elasticmember. In the example of FIG. 50A, a membrane or matrix can extendaround a spherical, or orbit-like, elastic member 82320 and through theinterstices defined by the plurality of circular, or ellipticalcomponents 82330, thereby embedding and fixing the elastic member 82320to and/or within the membrane or matrix.

FIG. 50B is an exploded view of a variation of the compressible elasticmember illustrated in FIG. 49. The hemispherical, or domed elasticmember 82322 includes a plurality of curvilinear components 82332affixed to a circular, or elliptical base 82342 and defining a threedimensional hemispherical, or domed shape. A person skilled in the artwill appreciate that such elastic members can include two or morecurvilinear components, which can be arranged in a regular or irregularpattern, fixed to a circular, elliptical, polygonal, or other twodimensional base. A person skilled in the art will also appreciate thatthe mechanical properties of such elastic members can be modulated, forexample, by appropriate selection of the material, size, shape,position, and/or number of curvilinear components and base. These andother elastic members can include one or more surface features, orfeatures of the three dimensional shape of the elastic member itself,configured to fix the membrane to the elastic member. In the example ofFIG. 50A, a membrane or matrix can extend around a curvilinear elasticmember 82332 and through the interstices defined by the plurality ofcurvilinear elastic members 82332 and/or base 82342, thereby embeddingand fixing the elastic member 82322 to and/or within the membrane ormatrix.

FIG. 50C is an exploded view of a variation of the compressible elasticmember illustrated in FIG. 48. The radially projecting, atom-like, orjack-like elastic members 82321 includes a nucleus 82331 from which arms82341 radiate and terminate in ball shaped end cap 82351. A personskilled in the art will appreciate that similar elastic members caninclude two or more arms, which are not necessarily straight or equal inlength, radiating from a nucleus, which is not necessarily the geometriccenter of the elastic member. A person skilled in the art will alsoappreciate that the mechanical properties of such elastic members can bemodulated, for example, by appropriate selection of the material, size,shape, position, and/or number of arms, end caps, and other features.These and other elastic members can include one or more surface featuresconfigured to fix the membrane to the elastic member (e.g., ball shapedend caps, shelves, barbs, and the like). Features such as ball shapedend caps may have addition advantageous features, such as blunting thetip of arm 82341, thereby preventing the arm from piercing or otherwisedisrupting an adjacent region of membrane or matrix. In the non-limitingexample of FIG. 50C, the elastic member 82321 has radially projectingarms 82341 and ball shaped end caps 82351 can be embedded in a membraneor matrix, thereby fixing the elastic member within the membrane ormatrix and mitigating movement of the elastic member within the membraneor matrix. A person skilled in the art will appreciate that othersurface features and configurations can be used in other embodiments.

A person skilled in the art will appreciate that shapes other than thoseillustrated in the examples of FIGS. 47-50C, e.g., spheroid, ovoid,three-dimensional radial, non-symmetrical form, and functionally similartwo or three-dimensional elastic member shapes, can be used inalternative embodiments. Likewise, the elastic member need notnecessarily assume a configuration of the illustrated embodiments (e.g.,disposed between a synthetic layer and a biologic layer and/or embeddedwithin a biologic layer—the spring member can be disposed in or oneither the biologic and/or synthetic layer, or disposed betweenlayers.). A person skilled in the art will also appreciate that themechanical properties (e.g., compression and spring back behavior) of ahybrid adjunct material can be modulated by appropriate selection of thenumber, type, and/or arrangement of elastic members. For example, thetype and/or arrangement of elastic members can be uniform (e.g., similarto FIG. 47), random (e.g., similar to FIG. 48), or patterned (e.g.,similar to FIG. 49, to concentrate compression and spring back aroundthe staples). Furthermore, in various embodiments, a hybrid adjunctmaterial can include two or more different types of elastic membersand/or two or more patterns (e.g., regular pattern of a first type ofelastic member at staple sites and a random pattern of a second type ofelastic member elsewhere).

Elastic members can be made from essentially any synthetic materialhaving the desired mechanical (e.g., springiness, recoverableviscoelasticity, reinforcement and the like) and biologic (e.g.,bioimplantable and bioabsorbable) properties. Representative examplesare discussed in the IMPLANTABLE MATERIALS section above. Likewise,essentially any shape and configuration having spring-like propertiescan be used, assuming compatibility (e.g., shape, volume) with thehybrid adjunct material. A person skilled in the art will appreciatethat the shape of hybrid adjunct materials (and layers thereof) are notlimited to the parallelepiped/rhombohedron like forms shown in theillustrated examples. In various embodiments, hybrid adjunct materials(and layers thereof) are not necessarily symmetrical as shown in FIGS.46-49 and can, for example, vary in thickness or have irregularly shapedportions.

In another aspect, the invention provides a method for staplingbiological tissue. FIGS. 51-53 illustrate an example of one such method,through operation of the exemplary staple cartridge encased by lower jaw91052 of an end effector shown in FIG. 46. While the example method isdiscussed with reference to FIG. 46, it is understood that this andother methods provided by the present invention are applicable to theuse of adjunct materials with different types of spring membersdiscussed herein.

FIG. 51 illustrates the engagement of tissue 93000 with a surgicalstapler cartridge body 91100 at a surgical site. The cartridge body91100 has a hybrid adjunct material 9600 releasably attached thereto.The material 9600 comprises a biologic tissue membrane 9604, a syntheticsubstrate layer 9602, and at least one compressible elastic member 9616configured to compress when a compressive force is applied thereto, andto provide a spring back force when the compressive force is removed.Here, the tissue 93000 is engaged between an anvil or upper jaw 91054and the lower jaw 91052, which encases the cartridge body 91100 havingstaples 91101 disposed therein, and which supports the hybrid adjunctmaterial 9600.

FIG. 52 illustrates an actuated surgical stapler that has ejectedstaples 91101 from the cartridge body 91100, and into the biologicaltissue 93000. The staples 91101 extend through the hybrid adjunctmaterial 9600 to maintain the material 9600 at the surgical site. Inthis example, actuation of the surgical stapler also cuts the tissue93000 at a surgical site between the staples 91101, as shown in FIG. 52.Further embodiments and examples of such cutting embodiments aredescribed above. However, the present invention also contemplatesembodiments where tissue is not necessarily cut, or where tissue is notnecessarily cut concurrently with actuation of the surgical stapler.

FIG. 53 illustrates the tissue 93000 following deployment of staples91101 and adjunct material 9600. As shown, the staples 91101 extendthrough the hybrid adjunct material 9600 and the tissue 93000 tomaintain the material 9600 at the surgical site. In this illustration,the tissue 93000 comprising the staples 91101 is reinforced by thehybrid adjunct material 9600, thereby preventing or mitigating tearing,fluid (e.g., blood), or other undesired damage to the surgical site.Avoiding undesired damage can decease surgical recovery time andmitigate surgical complications. Furthermore, the reinforcement canpromote healing through the action of the biologic matrix 9604 and/orbiologically active compounds therein. Similarly, the reinforcement canprevent or mitigate irritation and inflammation from synthetic materialbecause the elastic member or spring 9616 is internal to the biologictissue membrane or matrix 9604 and/or because the synthetic substratelayer 9602 essentially does not contact the tissue 93000. In alternativeembodiments, essentially all synthetic material can be encapsulated bybiologic material, to prevent or mitigate irritation and inflammationfrom synthetic materials.

Reuse

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination,e.g., electrodes, a battery or other power source, an externallywearable sensor and/or housing therefor, etc. Upon cleaning and/orreplacement of particular parts, the device can be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device can utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

In some embodiments, devices described herein can be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

Additional exemplary structures and components are described in U.S.application Ser. No. 14/074,884 entitled “Sealing Materials For Use InSurgical Stapling,” Ser. No. 14/074,810 entitled “Hybrid AdjunctMaterials For Use In Surgical Stapling,” Ser. No. 14/075,438 entitled“Positively Charged Implantable Materials And Method Of Forming TheSame,” and Ser. No. 14/074,902 entitled “Hybrid Adjunct Materials ForUse In Surgical Stapling,” which are filed on even date herewith andherein incorporated by reference in their entireties.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

1. A surgical stapling adjunct material comprising: a hybrid adjunctmaterial releasably retained on a cartridge or anvil body configured tocompress when a compressive force is applied thereto and to provide aspring back force when compressive force is removed, wherein the hybridadjunct material has a plurality of first synthetic fibers and aplurality of second synthetic fibers, wherein the plurality of firstsynthetic fibers comprises a first absorbable material and the pluralityof second synthetic fibers comprises a second absorbable material,wherein the plurality of first synthetic fibers and the plurality ofsecond synthetic fibers are intertwined to create interlocking patternsin a first region, and wherein the hybrid adjunct material comprises asecond region where only one of the plurality of first synthetic fibersor the plurality of second synthetic fibers is present and is arrangedin a pattern to provide an internal structure to provide verticalspringiness for the adjunct.
 2. The adjunct material of claim 1, whereinthe first synthetic fiber comprises Polyglactic
 910. 3. The adjunctmaterial of claim 1, wherein the first synthetic fiber comprisespolyglycolide-trimethylene carbonate.
 4. The adjunct material of claim1, wherein the second synthetic fiber comprises Polydioxanone.
 5. Theadjunct material of claim 1, wherein the adjunct material furthercomprises hydrophobic surface areas and hydrophilic surface areas. 6.The adjunct material of claim 5, where in the hydrophilic surface areasare on the tissue facing side of the adjunct.
 7. The adjunct material ofclaim 1, where in the first region comprises at least two syntheticmaterial fibers and at least one organic fiber.
 8. The adjunct materialof claim 7, where in the organic fiber is comprises oxidized regeneratedcellulose
 9. The adjunct material of claim 8, wherein the organic fiberchanges form in the presence of body fluids to form a hemostatic layer.10. The adjunct material of claim 1, wherein the adjunct material ispositively charged.
 11. A staple cartridge assembly for use with asurgical stapler, comprising: a cartridge body having a plurality ofstaples disposed therein; and a hybrid adjunct material configured to bereleasably retained to the cartridge body or anvil body and configuredto be securely attached tissue by the staples in the cartridge, tocompress when a compressive force is applied thereto, and to provide aspring back force when compressive force is removed, wherein the hybridadjunct material has a plurality of first synthetic fibers and aplurality of second synthetic fibers, wherein the plurality of firstsynthetic fibers comprises a first absorbable material and the pluralityof second synthetic fibers comprises a second absorbable material,wherein the plurality of first synthetic fibers and the plurality ofsecond synthetic fibers are intertwined to create interlocking patternsin a first region, and wherein the hybrid adjunct material comprises asecond region where only one of the plurality of first synthetic fibersor the plurality of second synthetic fibers is present and is arrangedin a pattern to provide an internal structure to provide verticalspringiness for the adjunct.
 12. The assembly of claim 11, wherein thefirst synthetic fiber comprises Polyglactic
 910. 13. The assembly ofclaim 11, wherein the first synthetic fiber comprisespolyglycolide-trimethylene carbonate.
 14. The assembly of claim 11,wherein the second synthetic fiber comprises Polydioxanone.
 15. Theassembly of claim 11, wherein the adjunct material further compriseshydrophobic surface areas and hydrophilic surface areas.
 16. Theassembly of claim 15, where in the hydrophilic surface areas are on thetissue facing side of the adjunct.
 17. The assembly of claim 11, wherein the first region comprises at least two synthetic material fibers andat least one organic fiber.
 18. The assembly of claim 17, where in theorganic fiber is comprises oxidized regenerated cellulose
 19. Theassembly of claim 18, wherein the organic fiber changes form in thepresence of body fluids to form a hemostatic layer.
 20. The assembly ofclaim 11, wherein the adjunct material is positively charged.